Adjunct materials and methods of using same in surgical methods for tissue sealing

ABSTRACT

Surgical methods involving cutting and sealing tissue include affixing a first adjunct material to tissue at a treatment site, such as by stapling the adjunct to tissue. A second adjunct material is applied to at least a portion of the first adjunct material such that the second adjunct material interacts with the first adjunct material to form a seal in an area of the tissue covered by at least one of the first and the second adjunct material. The resulting tissue sealing structure, which includes a combination of the two adjuncts, is believed to be superior to the sealing properties of either adjunct alone.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/806,252, filed Mar. 2, 2020, and entitled “ADJUNCT MATERIALSAND METHODS OF USING SAME IN SURGICAL METHODS FOR TISSUE SEALING,” whichis a continuation of U.S. patent application Ser. No. 16/119,292, filedAug. 31, 2018, now issued as U.S. Pat. No. 10,966,722, and entitled“ADJUNCT MATERIALS AND METHODS OF USING SAME IN SURGICAL METHODS FORTISSUE SEALING,” which is a continuation of U.S. patent application Ser.No. 14/300,954, filed Jun. 10, 2014, now issued as U.S. Pat. No.10,172,611, and entitled “ADJUNCT MATERIALS AND METHODS OF USING SAME INSURGICAL METHODS FOR TISSUE SEALING,” each of which is incorporatedherein by reference in its entirety.

FIELD

The subject matter disclosed herein relates to surgical instruments, andin particular to methods, devices, and components thereof for cuttingand stapling tissue.

BACKGROUND

Surgical staplers are used in surgical procedures to seal, divide,and/or transect tissues in the body by closing openings in tissue, bloodvessels, ducts, shunts, or other objects or body parts involved in theparticular procedure. The openings can be naturally occurring, such aspassageways in blood vessels, airways or an internal lumen or organ likethe stomach, or they can be formed by the surgeon during a surgicalprocedure, such as by puncturing tissue or blood vessels to form abypass or an anastomosis, or by cutting tissue during a staplingprocedure.

Most staplers have a handle with an elongate flexible or rigid shafthaving a pair of opposed jaws formed on an end thereof for holding andforming staples therebetween. At least one of the opposed jaws ismovable relative to the other jaw. In the case of laparoscopic surgery,often one jaw is fixed and the other is movable. In some devices (forexample an open linear stapler), the opposed jaws can be separated bythe operator and reassembled providing the relative motion needed fortissue placement. The staples are typically contained in a staplecartridge, which can house multiple rows of staples and is oftendisposed in one of the two jaws for ejection of the staples to thesurgical site. In use, the jaws are positioned so that the object to bestapled is disposed between the jaws, and staples are ejected and formedwhen the jaws are closed and the device is actuated. Some staplersinclude a knife configured to travel between rows of staples in thestaple cartridge to longitudinally cut the stapled tissue between thestapled rows. Placement of the device, manipulation of components orsystems of the device, and other actuations of the device such asarticulation, firing, etc. can be accomplished in a variety of ways,such as electromechanically, mechanically, or hydraulically.

There are various types of staplers suited for particular surgicalprocedures. For example, linear staplers include a handle with anelongate shaft having a pair of opposed jaws formed on an end thereoffor holding and forming staples therebetween. At least one of theopposed jaws is movable relative to the other. The staples are typicallycontained in a staple cartridge assembly, which can house multiple rowsof staples and is often disposed in one of the two jaws for ejection ofthe staples to the surgical site. Circular staplers have a handle and anelongate shaft with an anvil and a cartridge assembly disposed on adistal end of the elongate shaft, the anvil axially movable relative tothe cartridge assembly and configured to form staples therebetween anddeploy the staples into tissue.

While surgical staplers have improved over the years, a number ofproblems can potentially arise. Although rare, as illustrated in FIG. 1,one problem is that leaks can occur due to staples S forming tears Hwhen penetrating a tissue T or other object in which the staples S aredisposed. Blood, air, gastrointestinal fluids, and other fluids can seepthrough the tears H formed by the staples S, even after the staples Sare fully formed. The tissue T being treated can also become inflameddue to the manipulations and deformations that can occur duringstapling. Still further, staples, as well as other objects and materialsimplanted during stapling procedures, generally lack the samecharacteristics as tissue in which they are implanted. For example,staples and other objects and materials can lack the natural flexibilityof the tissue in which they are implanted. A person skilled in the artwill recognize that it is often desirable for tissue to maintain as muchof its natural characteristics as possible after staples are disposedtherein.

In the particular case of stapling bronchial tubes, such as during lungresection, it is important for no leaks to be present after stapling sothat air does not inappropriately enter or exit the lung and/or thethoracic cavity. Air escaping a stapled bronchial tube through a leakcan interfere with breathing and lung function, such as by preventingfull intake of air. Air exiting a stapled bronchial tube into thethoracic cavity through a leak is unsterile and can cause infectionand/or other complications in the otherwise sterile environment of thethoracic cavity. However, it can be difficult to prevent leaks inbronchial tubes for a variety of reasons. The small size of bronchialtubes can make delivery of any sealing materials into bronchial tubesdifficult, inflammation due to implanted staples and/or other objectsand materials can cause bronchial tubes to close or nearly close sincethey have small diameters, and/or it can be difficult for sealingmaterials introduced into a bronchial tube to withstand the repeatedexpansion and contraction of the lung without failing and/or movingwithin the tube so as to break the seal of the bronchial tube.

In the particular case of stapling a colon, it is important that thestaple line of the anastomosis is substantially sealed so thatgastrointestinal solids and fluid remain in the organ. Leakage from thetubular body organ, e.g. a colon, can interfere with normal digestivefunction and can introduce bacteria into other portions of the body,causing infection. However, it can be difficult to prevent leaks in atubular body organ for a variety of reasons. For example, it can bedifficult for the tissue disposed near the staple line to withstandrepeated expansion and contraction that occurs when solids and fluidpasses through the colon. Additionally, it can be difficult to deliversealant to the tubular body organ and control the position of thesealant when it is curing from a liquid state to a solidified state

Accordingly, there remains a need for improved devices, materials, andmethods for stapling tissue, or other objects or body parts such thatleaking and inflammation is minimized while substantially maintainingthe natural characteristics of the treatment region.

SUMMARY

A staple cartridge for use with a surgical stapler is provided and caninclude a cartridge body and an adjunct material. The cartridge body canhave a plurality of staple cavities configured to seat staples therein.The adjunct material can be mated to the cartridge body and configuredto be detached therefrom as the staples are deployed from the cartridgebody and into tissue. The adjunct material can include a solid centralportion sized and shaped to substantially correspond to the cartridgebody, and a wing portion extending along at least two sides of the solidcentral portion such that the wing portion extends beyond a lateralboundary of the cartridge body in a direction traverse to a longitudinalaxis of the cartridge body.

The solid central portion of the adjunct material can vary in any numberof ways. For example, the solid central portion of the adjunct materialcan be substantially rectangular shaped. In certain aspects, the solidcentral portion can include first and second opposed edges. In otheraspects, the wing portion can extend along the first and second opposededges of the adjunct material. In use, the solid central portion can beconfigured to reinforce a seal around staples when the adjunct materialand the staples are coupled to tissue.

The wing portion can have various features. For example, the wingportion can include rounded corners. For another example, the wingportion can have a mesh structure. In certain aspects, the wing portioncan have plurality of openings formed therein. In use, the wing portioncan be configured to distribute or otherwise alter a strain ordeformation present in tissue beyond the staple line when the adjunctmaterial is disposed on tissue.

The solid and wing portions can be formed from various materials. Incertain aspects, the solid and wing portions can be formed from a singlepolymer. In certain aspects, the solid and wing portions can be formedfrom more than one material or type of material. In certain aspects, thesolid and wing portions can be formed from different materials. In otheraspects, the wing portion can be more flexible than the solid centralportion of the adjunct material.

An end effector for a surgical instrument is provided and can includefirst and second jaws, the first jaw having a cartridge body removablyattached hereto and the cartridge body having a plurality of staplecavities configured to seat staples therein. The second jaw can includean anvil with a plurality of staples forming openings formed therein, atleast one of the first and second jaws being movable relative to theother jaw. The end effector can include a buttress having a widthgreater than a width of at least one of the cartridge body and theanvil, the buttress having a compressible, central region configured toseal around a staple and a strain relief region adjacent to thecompressible region. The strain relief region can have a plurality ofopenings formed therein and the strain relief region can extend from atleast two sides of the central region. In use, the buttress can bereleasably retained on at least one of the cartridge body and the anviland can be configured to be released therefrom upon deployment ofstaples from the cartridge body and into the compressible region of thebuttress.

The end effector can vary in a number of ways. In certain aspects, theplurality of openings include slits. When the buttress and the staplesare deployed into tissue, the plurality of slits can extend parallel tolongitudinal axes of the staples. In other aspects, the plurality ofopenings are spaced apart such that the strain relief region is moreflexible along a lateral portion thereof than a portion of the strainrelief region adjacent to the compressible region. In other aspects, theplurality of openings are shaped and spaced apart such that the strainrelief region is more flexible along a longitudinal portion thereof thana portion of the strain relief region adjacent to the compressibleregion.

A method for implanting a tissue reinforcement material onto tissue isprovided and includes engaging tissue between a cartridge assembly andan anvil of a surgical stapler at a surgical site, at least one of thecartridge assembly and the anvil having a tissue reinforcement materialreleasably retained thereon. The tissue reinforcement material caninclude a compressible, central region configured to seal around astaple and a flexible supportive region adjacent to the central regionand defining an edge of the tissue reinforcement material. Actuating thesurgical stapler can eject staples from the cartridge assembly so as toform a staple line through the central region and into the tissue tohold the tissue reinforcement material at the surgical site.

The method can vary in any number of ways. For example, actuating thesurgical stapler can eject the staples through the central region anddoes not eject the staples through the flexible supportive region of thetissue reinforcement material. In certain aspects, the cartridgeassembly and the anvil can be inserted into the surgical site with theflexible supportive region folded around at least one of the cartridgeassembly and the anvil. Actuating the surgical stapler can advance acutting member through the tissue reinforcement material and releasesthe tissue reinforcement material from the surgical stapler. In certainaspects, actuating the surgical stapler advances the cutting memberthrough the central region of the tissue reinforcement material.

Methods for implanting a tissue reinforcement material onto tissue areprovided. The method can include engaging tissue between a cartridgeassembly and an anvil of a surgical stapler at a surgical site, at leastone of the cartridge assembly and the anvil having a tissuereinforcement material retained thereon. The tissue reinforcementmaterial can include a central region configured to provide a sealaround a staple penetration site (e.g. in the tissue, in the centralregion, etc.) and an outer region adjacent to the central region anddefining an edge of the tissue reinforcement material. Actuating thesurgical stapler can eject staples from the cartridge assembly so as toform a staple line through the central region and into the tissue tohold the tissue reinforcement material at the surgical site. Afteractuating the surgical stapler, sealant can be delivered to the tissuereinforcement material when the sealant is in a first, liquid state suchthat the sealant solidifies thereon and reinforces a seal of the tissueat the staple line.

The method can vary in any number of ways. In certain aspects, actuatingthe surgical stapler ejects the staples through the central region ofthe tissue reinforcement material. The method can further includeinserting the cartridge assembly and the anvil into the surgical sitewith the outer region of the tissue reinforcement material folded aroundat least one of the cartridge assembly and the anvil. Actuating thesurgical stapler can release the tissue reinforcement material from thesurgical stapler. In certain aspects, the surgical stapler advances thecutting member through the central region of the tissue reinforcementmaterial. In other aspects, the surgical stapler forms a staple linehaving at least two rows of staples.

The sealant can be delivered to tissue in various ways. In certainaspects, the sealant is delivered through an applicator tool positionedadjacent to the tissue reinforcement material. Delivering the sealantcan include depositing the sealant onto both the central and outerregions of the reinforcement material. In certain aspects, the sealantis delivered to the tissue reinforcement material in the first, liquidstate, and the sealant penetrates a space in the tissue at the stapleline and solidifies therein.

Systems for reinforcing a tissue seal are also provided. The system caninclude a sealant, a container, and an applicator tool. The sealant canbe configured to transition from a first liquid state to a second solidstate. The container can be configured to retain the sealant thereinwhen the sealant is in the first liquid state, the container having afirst port for receiving a gas and a second port for outputtingnebulized sealant. The applicator tool can be coupled to the second portof the container, the applicator tool being configured to deliver thenebulized sealant to a surgical site.

The system can vary in any number of ways. In certain aspects, theapplicator tool is a trocar. In other aspects, the gas includes carbondioxide. In other aspects, the sealant includes a mixture of collagen,fibrinogen, and thrombin. These biologic materials may be derived fromhuman and/or animal sources. The sealant can be configured to transitionfrom the first liquid state to the second solid state after apredetermined amount of time. The system can include additionalcomponents. For example, a first tube can extend between the second portof the container and the applicator for receiving nebulized sealant.

Methods for delivering sealant to a body of a patient are also provided.The method can include delivering gas to a container having a sealantretained therein, thereby transitioning the sealant from a first, liquidstate to a second, nebulized state. The nebulized sealant can bedelivered through an applicator tool extending through an access port ina patient, the nebulized sealant solidifying onto tissue and forming aseal thereon.

The method can be performed in various ways. For example, the applicatortool can be positioned in a thoracic cavity of a patient prior todelivering the gas to the container. In certain aspects, the applicatortool includes a trocar, and nebulized sealant is delivered directlythrough the trocar and into the patient. The method can includepositioning a distal end of the applicator tool adjacent to a stapleline in the tissue prior to delivering the nebulized sealant to thetissue. In certain aspects, the hardened sealant is absorbed into thebody after a predetermined passage of time.

Some embodiments relate to a staple cartridge assembly for use with asurgical stapler. In one embodiment, the staple cartridge assembly caninclude a cartridge body having a plurality of staple cavitiesconfigured to seat staples therein, and a tissue reinforcement constructremovably attached to the cartridge body and configured to be deliveredto tissue by deployment of the staples in the cartridge body. The tissuereinforcement construct can include a first, absorbable materialencompassing a swellable, hydrophilic second material such that thesecond material is maintained within the first material in a constrainedconfiguration. The second material can have a preconfigured shape suchthat, in an unconstrained configuration, the second material is adaptedto expand to the preconfigured shape in which a peripheral edge portionof the second material has a thickness that is greater than a centralportion of the second material.

The assembly can have any number of variations. For example, at least aportion of the first material can be less hydrophilic than the secondmaterial. For another example, the first material can be brittle. Foryet another example, the second material can include a foam material.For another example, the first material can be selectively dissolvablesuch that portions of the first material encompassing the peripheraledge portions of the second material are adapted to dissolve at a fasterrate than portions of the first material encompassing the centralportion of the second material. For still another example, the firstmaterial can include at least one first portion and at least one secondportion, and the first material can be selectively dissolvable such thatthe at least one first portion is adapted to dissolve at a faster ratethan the at least one second portion. For another example, the firstmaterial can be selectively absorbable such that portions of the firstmaterial encompassing the peripheral edge portions of the secondmaterial are adapted to absorb at a faster rate than portions of thefirst material encompassing the central portion of the second material.For yet another example, the first material can include at least onefirst portion and at least one second portion, and the first materialcan be selectively absorbable such that the at least one first portionis adapted to absorb at a faster rate than the at least one secondportion. For another example, the first material can be selected fromthe group consisting of polydioxanon, polyhydroxyalkanoate (PHA),polyglycerol sebacate (PGS), polyglycolic acid, polylactic acid (PLA),poliglecaprone 25, polyglactin 910, poly glyconate, polyglycolide (PGA),polyglycolide-trimethylene carbonate (PGA/TMC), polyhydroxybutyrate(PHB), poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA),absorbable polyurethanes, a blend thereof, and a copolymer thereof. Forstill another example, the second material can be selected from thegroup consisting of polydioxanon, polyhydroxyalkanoate (PHA),Polyglycerol sebacate (PGS), polyglycolic acid, polylactic acid (PLA),poliglecaprone 25, polyglactin 910, poly glyconate, polyglycolide (PGA),polyglycolide-trimethylene carbonate (PGA/TMC), polyhydroxybutyrate(PHB), poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA),absorbable polyurethanes, a blend thereof, and a copolymer thereof. Foryet another example, the assembly can include at least one therapeuticagent incorporated into at least one of the first material and thesecond material, and the at least one therapeutic agent can be effectiveto be released upon one of absorption of the first material andexpansion of the second material upon exposure to moisture. For anotherexample, the tissue reinforcement construct can be shaped such that across-section of the peripheral edge portion of the tissue reinforcementconstruct is larger than a cross-section of the central portion of thetissue reinforcement construct, and the central portion can be closer toa longitudinal axis of the tissue reinforcement construct than theperipheral edge portion. The preconfigured shape can be such that thecentral portion of the second material transitions to a large radius atthe peripheral edge.

In another embodiment, a staple cartridge assembly for use with asurgical stapler can include a cartridge body having a plurality ofstaple cavities configured to seat staples therein, and an adjunctmaterial releasably retained on the cartridge body and configured to bedelivered to tissue by deployment of the staples in the cartridge body.The adjunct material can include a first material encompassing a secondmaterial. The adjunct material can be configured to be penetrated by thestaples being delivered to the tissue such that the first material ispenetrated so as to expose the second material to moisture, and thesecond material can be configured to expand to form a seal around atleast one staple of the staples inserted therethrough upon the exposureto moisture.

The first material can be formed from a variety of materials;particularly advantageous are those materials that are absorbable andcapable bearing compressive and bending loads. They may be present incontinuous form so as to fully encapsulate the materials making up thecenter of the device, or alternately they might be present in anon-continuous form. These non-continuous forms include, but are notlimited to, otherwise encapsulating forms with minute openings allowingwater or bodily fluids to access the materials making up the center ofthe device to facilitate rapid hydration to allow expansion of thecenter material; melt blend nonwoven forms with controlled porosity;immiscible polymer blends having a major blend component an absorbablepolymer and a minor component being a biocompatible water solublepolymer which is capable of rapidly dissolving creating conduits to thecentral material allowing for its rapid hydration to generate anexternal force on the tissue.

The absorbable polymer making up the outer layer, although not limitedto, can be selected from the group consisting of polydioxanone [AKApoly(1,4-dioxan-2-one), or poly(p-dioxanone)]; polyglycolide [AKApolyglycolic acid], polylactide [AKA polylactic acid] in all its formsbased on the ring-opening of the corresponding lactone monomers,L(−)-lactide, D(+)-lactide, and meso-lactide, as well as all of itsforms based upon polycondensation of L(+)-lactic acid and D(−)-lacticacid [e.g. poly(L(−)-lactide), poly(D(+)-lactide), poly(meso-lactide),poly(racemic-lactide), poly(L-lactic acid), poly(D-lactic acid), etc.];the polycaprolactones, especially poly(epsilon-caprolactone);polyhydroxyalkanoate (PHA); the absorbable copolymers usually formed bythe ring-opening polymerization of the lactone monomers, L(−)-lactide,(D+)-lactide, meso-lactide, glycolide, 1,4-dioxan-2-one, trimethylenecarbonate, and the caprolactones, especially epsilon-caprolactone, inany molar combination or in an sequential distribution. These latercopolymers include, but are not limited toepsilon-caprolactone/glycolide copolymers such as 25/75poly(caprolactone-co-glycolide) [AKA poliglecaprone 25], 10/90poly(L(−)-lacide-co-glycolide) [AKA polyglactin 910], polyglyconate,polyglycolide-trimethylene carbonate (PGA/TMC). The absorbable polymercan be a miscible or immiscible blend of the previously mentionedpolymers [and copolymers] in any combination. It will be clear to oneskilled in the art to select a biocompatible material.

The second material may be formed from a variety of materials.Advantageous materials include those that are absorbable and can undergoa controlled degree of swelling so as to create an external force on thetissue. Swelling might be accomplished by hydration based on an influxof water or bodily fluids. One class of materials that is particularlyadvantageous are absorbable dehydrated hydrogels. These include thematerials described in U.S. Pat. No. 5,698,213, entitled “Hydrogels ofAbsorbable Polyoxaesters” and crosslinked aliphatic polyoxaesterscontaining amine and/or amido groups and blends thereof with otherpolymers as described in U.S. Pat. No. 5,700,583, each of which isincorporated herein by reference in its entirety. Other materialssuitable for the second material include water soluble polymers such aspoly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), andpolyethylene glycol (PEG) or the higher molecular weight polyethyleneoxide (PEO). Additionally suitable are absorbable polyurethanes. It isto be understood that suitable materials include copolymers that containa hydrophilic section and an absorbable polyester section; this wouldinclude, by way of example, the copolymer made by reaction of arelatively low molecular weight alpha,omega-dihydroxy polyethyleneglycol and a lactone monomer such as L(−)-lactide, (D+)-lactide,meso-lactide, glycolide, 1,4-dioxan-2-one, trimethylene carbonate, andthe caprolactones, especially epsilon-caprolactone, in any molarcombination or in an sequential distribution. Blends of materials andcopolymers formed from a wide variety of suitable monomers, some alreadymentioned above, may be suitable. It will be clear to one skilled in theart to select a biocompatible material.

The assembly can have any number of variations. For example, the adjunctmaterial can be positioned on the cartridge body such that at least aportion of the adjunct material extends beyond the cartridge body.

In another aspect, a method for joining tissue is provided that in oneembodiment can include engaging tissue between a cartridge assembly andan anvil of a surgical stapler at a surgical site. At least one of thecartridge assembly and the anvil can have an adjunct material releasablyretained thereon. The adjunct material can include a first material, atleast a portion of which being configured to dissolve when exposed tobodily fluid, and a second material constrained within the firstmaterial in a constrained form. The method can further include actuatingthe surgical stapler to eject staples from the cartridge into the tissuesuch that at least one staple from the staples extends through theadjunct material to maintain the material at the surgical site. Thesecond material can be configured to transition to a predetermined shapeupon dissolution of the first material such that at least a peripheraledge portion of the adjunct material has a thickness greater than acentral portion of the adjunct material. The method can have any numberof variations.

Adjunct materials for use with end effectors like surgical staplingdevices, and methods for using the same, are generally provided. In someembodiments a staple cartridge assembly for use with a surgical staplercan include a cartridge body having a plurality of staple cavitiesconfigured to seat staples therein and a biocompatible, compressibleadjunct material releasably retained on the cartridge body. The adjunctmaterial can be configured to be delivered to tissue by deployment ofthe staples in the cartridge body. The adjunct material can be a wovenmatrix such that the material can have a compressible elastic core layerconfigured to compress upon application of a compressive force andexpand upon removal of the compressive force, and at least one flexiblesupportive layer coupled to at least one side of the compressibleelastic core layer. In some embodiments, the adjunct material cancontain a therapeutic substance such as a drug or other medicament.Additionally, in some embodiments the adjunct material can beselectively strengthened in certain areas.

The adjunct material can be a woven matrix such that the adjunctmaterial will provide tissue support for tissue within and surroundingthe staple line. In one embodiment, woven 3-D structures are created andcompressed or otherwise formed into different shapes that have a higherdensity and different mechanical properties. This woven structure allowsthe adjunct to have different material characteristics in the compressedand uncompressed states. The amount of material and degree ofcompression can be used to determine the mechanical properties of theresultant brick. Multiple fiber types can be used in the weave to giveit additional properties of interest including compressibility, abrasionresistance, bioabsorption profile, fluid absorption profile, substanceelution characteristics, ability to be cut with a knife, ability toswell.

In other aspects, an end effector for a surgical instrument is provided.The end effector can include a first jaw having a cartridge bodyremovably attached hereto, the cartridge body having a plurality ofstaple cavities configured to seat staples therein, a second jaw havingan anvil with a plurality of staples forming openings formed therein.The adjunct material can be releasably retained on at least one of thetissue contacting surfaces of the cartridge body and the anvil so thatit can be delivered to tissue upon deployment of the staples. Theadjunct material can be comprised of a compressible elastic regionconfigured to compress upon application of a compressive force andexpand upon removal of the compressive force, and at least one flexiblesupportive region adjacent to the compressible elastic region.

In other aspects a method for stapling tissue is provided. The methodcan include engaging tissue between a cartridge assembly and an anvil ofan end effector, one of which has an adjunct material releasableretained thereon, and actuating the end effector to eject staples fromthe cartridge assembly into tissue. The staples can extend through theadjunct material to maintain the adjunct material at the surgical site.

Embodiments described herein address these and other challenges byproviding, for example, adjunct materials that seal punctures made bysurgical staples in tissue. The adjunct materials described herein havea number of embodiments, including embodiments in which an adjunct isdisposed about a single staple or leg thereof, or about a group ofstaples. Various embodiments disclosed herein include adjuncts that sealstaples in tissue from the crown, or staple cartridge, side, or from theanvil or staple leg side (or both).

In one aspect, for example, a staple cartridge assembly for use with asurgical stapler is provided that can include a cartridge body having aplurality of staple cavities, where each staple cavity has a surgicalstaple disposed therein. The assembly can further include a plurality ofadjuncts, where each adjunct can be disposed around at least one leg ofa surgical staple such that each adjunct forms a seal around the atleast one leg of the surgical staple upon deployment of the surgicalstaple from the cartridge body.

The assembly can have a number of different features and/ormodifications, all of which are considered within the scope of theinvention. For example, the adjuncts can have a number of differentshapes and sizes. In some embodiments, for example, each of theplurality of adjuncts can be in the form of a plug. In certainembodiments, for each surgical staple of the assembly, a first adjunctplug can be disposed around a first leg of the surgical staple and asecond adjunct plug can be disposed around a second leg of the surgicalstaple such that the first and second adjunct plugs form a seal aroundthe first and second legs of the surgical staple.

In other embodiments, each of the plurality of adjuncts can be in theform of a pledget configured to seal around both a first leg and asecond leg of a surgical staple. The pledget itself can have a number ofdifferent shapes and sizes. For example, in some embodiments the pledgetcan be in the form of a rectangular box extending along a length of acrown of a staple. Any of a variety of other shapes are also possible.

In still other embodiments, each of the plurality of adjuncts can be inthe form of a coating disposed around a leg of a surgical staple. Theadjuncts can be disposed about solely the legs of a staple (or a portionthereof), or about the entirety of a staple.

In addition to shape and/or size, the plurality of adjuncts can also beformed from a variety of materials. For example, in some embodimentseach of the plurality of adjuncts can be formed from a swellablematerial that expands upon contact with body fluids. Forming theadjuncts from such a material can enhance the adjuncts' ability to seala puncture in tissue created by a staple leg. Any of a variety ofbiocompatible swellable materials can be employed. For example, incertain embodiments, the swellable material can be a hydrogel. In yetother embodiments, each of the plurality of adjuncts can be formed fromother materials, such as a foam.

The plurality of adjuncts can be located at a variety of positions withrespect to the plurality of staples, and can be configured in certainembodiments to move relative to a staple during implantation in tissue.For example, in certain embodiments each of the plurality of adjunctscan be positioned adjacent to a crown of a surgical staple prior todeployment from the cartridge body. In other embodiments, each of theplurality of adjuncts can be positioned at a distal end of the at leastone leg of the surgical staple opposite a crown of the surgical stapleprior to deployment from the cartridge body. In such an embodiment, forexample, each of the plurality of adjuncts can be configured to slideover the at least one leg of the surgical staple. By way of furtherexample, if an adjunct is positioned at a distal end of a staple leg,the action of forcing the staple leg through tissue can slide theadjunct toward a crown of the staple such that the adjunct is sandwichedbetween the tissue and the crown of the staple, thereby sealing thepuncture created by the staple leg. In other embodiments, adjuncts canbe positioned at other locations, such as on an anvil of a surgicalstapler opposite the cartridge body, as described in more detail below.

In another aspect, a staple cartridge assembly for use with a surgicalstapler is provided that can include a cartridge body having a pluralityof staple cavities and a plurality of surgical staples disposed withinthe plurality of staple cavities and configured to be ejected therefrominto tissue. The assembly can also include a plurality of sealingadjuncts disposed within the plurality of staple cavities and configuredto be ejected therefrom along with the plurality of surgical stapleswithout contacting the cartridge body. By avoiding contact between thecartridge body and the sealing adjuncts, the adjuncts can be preventedfrom interfering with sliding movement of the staples relative to thecartridge body.

The adjuncts can be prevented from contacting the cartridge body in anumber of different ways. For example, in some embodiments each of theplurality of sealing adjuncts can be positioned such that a surgicalstaple shields the sealing adjunct from contact with the cartridge bodyduring ejection. This can be accomplished, for example, by coupling oneor more sealing adjuncts to a staple so that the staple leads theadjunct as it is ejected from the cartridge body, thereby shielding theadjunct from contact with the cartridge body.

Other configurations for coupling adjuncts to a staple are alsopossible. For example, in certain embodiments, each of the plurality ofsealing adjuncts can be positioned adjacent to a junction between a legof a surgical staple and a crown of the surgical staple.

In still other embodiments, each of the plurality of staple cavities canbe shaped to accommodate passage of at least one sealing adjunct coupledto a surgical staple. For example, each of the plurality of staplecavities includes at least one cut-out formed on opposing ends of thestaple cavity to accommodate the at least one sealing adjunct.

As mentioned above, the adjuncts can be formed from a variety ofbiocompatible materials and have any of a variety of shapes and/orsizes. In some embodiments, each of the plurality of sealing adjunctscan be configured to expand in volume upon contact with tissue.

In another aspect, a method for stapling tissue is provided that caninclude engaging tissue between a cartridge assembly and an anvil on asurgical stapler, and actuating the surgical stapler to eject at leastone staple from the cartridge assembly into the tissue. Further, atleast one leg of the at least one staple can extend through a sealingadjunct such that the adjunct forms a seal between the tissue and theleg.

In some embodiments, the sealing adjunct can be coupled to a distal endof the at least one leg of the at least one staple. In such anembodiment, actuating the surgical stapler can cause the adjunct toslide toward a crown of the at least one staple and seal a hole formedin the tissue by the at least one leg. In other embodiments, however,the sealing adjunct can be coupled to a crown of the at least one stapleand actuating the surgical stapler can cause the adjunct to eject fromthe cartridge assembly with the crown such that the sealing adjunct isdisposed between the crown of the at least one staple and the tissue.

As mentioned above, various embodiments described herein can includesealing adjuncts positioned away from the crown of a surgical staple,such as on the opposite side of stapled tissue near staple legs that aredeformed by an anvil of a surgical stapler. And, in some embodiments,adjuncts can be positioned at both locations to seal punctures from bothsides of the tissue and/or staple.

In one aspect, a surgical device includes an end effector that caninclude first and second jaws, where the first jaw has a cartridge bodyremovably attached thereto and the second jaw having an anvil. Thecartridge body can have a plurality of staple cavities configured toseat staples therein and the anvil can have a plurality of stapleforming openings formed therein. Further, at least one of the first andsecond jaws can be movable relative to the other jaw. The end effectorcan also include a plurality of sealing adjunct segments coupled to oneanother and at least one of the first and second jaws such that a stapleejected from the cartridge body passes through one of the plurality ofsealing adjunct segments and tissue disposed between the first andsecond jaws.

In some embodiments, each of the plurality of sealing adjunct segmentscan span a plurality of staple forming openings. In other embodiments,however, each of the plurality of sealing adjunct segments can cover asingle staple forming opening.

The plurality of sealing adjunct segments can be coupled to one anotherin a variety of manners. For example, in some embodiments each of theplurality of sealing adjunct segments can be coupled to one another by aplurality of connecting branches. Further, at least one of the first andsecond jaws can includes a plurality of features formed thereon that areconfigured to sever the plurality of connecting branches when deployingstaples into tissue disposed between the first and second jaws.Destroying the connecting branches between sealing adjuncts can allowfor greater compliance of tissue between adjacent staples, therebyreducing forces that can otherwise act to enlarge a puncture surroundinga staple leg.

In other embodiments, the plurality of sealing adjunct segments can becoupled to one another by a plurality of threads, or by a woven mesh. Instill other embodiments, the plurality of sealing adjunct segments canbe coupled to one another by a connective film extending over a surfaceof at least one of the first and second jaws. The connective film can,in some embodiments, have a first thickness and each of the plurality ofsealing adjunct segments can have a second, greater thickness. Incertain embodiments, the greater thickness of the sealing adjunctsegments can extend into the plurality of staple forming openings. Theplurality of sealing adjunct segments in such an embodiment does notsignificantly reduce the available clearance between the jaws of asurgical stapler, thereby allowing use with thicker tissue.

In addition to features that sever connections between sealing adjunctsegments, at least one of the first and second jaws of the end effectorcan include one or more features formed thereon that are configured toat least one of align and secure the plurality of sealing adjunctsegments thereto. Such features can be configured to mate withcomplementary features coupled to the plurality of sealing adjuncts suchthat the plurality of sealing adjuncts can be temporarily coupled to theend effector in a proper position and/or orientation. Examples of suchfeatures can include hooks and loops, plastic retainers, etc.

In certain embodiments, the plurality of sealing adjunct segments canhave the same shape and can be arrayed in a repeating pattern over alength of the end effector. In other embodiments, the plurality ofsealing adjunct segments can have a plurality of shapes and can bearrayed in an alternating pattern over a length of the end effector.Regardless, the plurality of sealing adjunct segments can cover each ofthe plurality of staple cavities such that each staple ejected intotissue passes through one of the plurality of sealing adjuncts.

In another aspect, an end effector for a surgical instrument is providedthat includes first and second jaws, the first jaw having a cartridgebody removably attached thereto and the second jaw having an anvil witha plurality of staple forming openings formed therein. The cartridgebody can have a plurality of staple cavities configured to seat staplestherein and at least one of the first and second jaws can be movablerelative to the other jaw. The end effector can further include aviscous sealant disposed within the plurality of staple forming openingsof the anvil, wherein the viscous sealant within each staple formingopening is retained therein by a film extending across the stapleforming opening. In such an embodiment, the plurality of discretepockets of viscous sealant can be the plurality of sealing adjunctsegments described herein.

In some embodiments, the film extending across each staple formingopening can be formed from viscous sealant that is at least partiallycured by exposure to any of a chemical, ultraviolet light, and heat. Inother embodiments, however, the film extending across each stapleforming opening can be formed from a second material overlaid on theviscous sealant.

In addition the film extending across each staple forming opening, insome embodiments each of the plurality of staple forming openings caninclude at least one retainer formed thereon to aid in retaining theviscous sealant within the opening. Further, while in some embodimentsthe film can extend solely across each staple forming opening of theanvil, in other embodiments the film can also extend between adjacentstaple forming openings.

In another aspect, a surgical method is provided that can includefilling a plurality of staple forming openings in an anvil of a surgicalstapler with a viscous sealant, and forming a film over the plurality ofstaple forming openings in the anvil such that the film retains theviscous sealant within the staple forming openings.

As mentioned above, in certain embodiments forming the film can includeat least partially curing the viscous sealant by exposure to any of achemical, ultraviolet light, and heat.

In other embodiments, however, forming the film can include overlaying asecond material over the viscous sealant disposed within the stapleforming openings.

In still other embodiments, the method can further include actuating thesurgical stapler to drive a plurality of staples through tissue and intothe plurality of staple forming openings such that the plurality ofstaples puncture the film and the viscous sealant forms a seal aroundthe plurality of staples.

A surgical device is provided in the form of an applicator for couplingadjunct material to a surgical stapler. In one aspect, for example, asurgical device is provided that can include at least one nozzle formedat a proximal end of the device that is configured to receive a sealant,and an applicator formed at a distal end of the device that isconfigured to deliver the sealant received by the at least one nozzle.In one aspect, the applicator can be removably and replacably attachedto the nozzle. The applicator can be configured to interface with atleast one of a first and second jaw of a surgical stapler such that thesealant delivered from the applicator can be deposited into a pluralityof openings formed in the surgical stapler. The plurality of openingscan be, for example, any of a plurality of staple cavities located in acartridge body, or a plurality of staple forming openings formed in ananvil.

In some embodiments, it can be desirable to prevent adjunct material,such as the sealant, from being deposited in certain areas of a surgicalstapler. For example, in some embodiments, it can be desirable to keep acutting member guide path free from sealant. Accordingly, in someembodiments, the surgical device can include a shield disposed withinthe applicator such that the shield prevents the sealant delivered bythe applicator from entering a cutting guide slot formed in at least oneof the first and second jaw of the surgical stapler.

Still further, it can be desirable to remove any excess sealant from thesurgical stapler prior to use. In some embodiments then, the surgicaldevice can include a squeegee formed on a distal-most edge of theapplicator to remove excess sealant.

There are a variety of biocompatible sealants that can be used with thedevices and methods described herein. Certain of these sealants can bemulti-part, such as two-part sealants that must be mixed before beingcoupled to the surgical stapler. Therefore, in some embodiments, thesurgical device can include two nozzles formed at a proximal endthereof, and the applicator can include a common lumen extendingtherethrough to allow sealant received from each nozzle to mix beforebeing delivered from a distal end of the applicator. In still otherembodiments, the two nozzles can be configured to introduce sealant intothe common lumen at different rates, e.g., for multi-part sealants thatrequire components at various mixing ratios.

In some embodiments, the surgical device can further include a containerof sealant coupled to the at least one nozzle. The container can besealed for sterility purposes in certain embodiments, and the at leastone nozzle can include a piercing tip configured to puncture a sealformed on the container. The container can have any of a variety ofshapes and/or sizes. In some embodiments, however, the container can bea syringe.

In another aspect, a method for applying sealant to a surgical device isprovided that can include applying a viscous sealant to a jaw member ofa surgical stapler, wherein the jaw member includes a plurality ofopenings formed therein that can receive the sealant. The method canfurther include removing excess viscous sealant from the jaw member suchthat only sealant deposited within the plurality of openings remains.

The viscous sealant can be applied to the jaw member in a variety ofmanners. For example, in some embodiments applying the viscous sealantto the jaw member can include sliding an applicator along a length ofthe jaw member as sealant is introduced through the applicator. Further,in certain embodiments removing excess viscous sealant can includesliding a squeegee along a length of the jaw member. In someembodiments, the applicator can include a squeegee formed on adistal-most edge thereof to allow both sealant application and removalof excess sealant with a single pass over the jaw member.

In order to help retain the viscous sealant within the plurality ofopenings of the jaw member (e.g., staple cavity openings in a cartridgebody or staple forming openings in an anvil), the method can furtherinclude at least partially curing the viscous sealant after applicationto the jaw member. At least partially curing the viscous sealant cancreate a hardened layer extending across the opening that can retain theuncured sealant within the opening until, for example, ejection of astaple from the surgical stapler punctures the hardened layer of thesealant. Curing the viscous sealant can be accomplished in a variety ofmanners, including, for example, by exposing the sealant to any of achemical, ultraviolet light, and heat.

In a further aspect, a method for stapling tissue is provided that caninclude applying a non-compressible sealant into a plurality of stapleforming openings formed in an anvil of a surgical stapler, andcompressing tissue between the anvil and a cartridge body of thesurgical stapler. The method can further include actuating the surgicalstapler to deliver a plurality of staples from the cartridge bodythrough the tissue and into the plurality of staple forming openingscontaining the non-compressible sealant. The non-compressible sealantcan prevent tissue compressed between the anvil and the cartridge bodyfrom entering the plurality of staple forming openings upon actuation ofthe surgical stapler. This can be beneficial to prevent staples frombeing formed within tissue (i.e., without being passed completelythrough tissue).

As in the embodiments described above, applying the non-compressiblesealant can, in certain embodiments, include sliding an applicator alonga length of the anvil. In other embodiments, applying thenon-compressible sealant can include mixing a multi-part sealant justprior to delivery into the plurality of staple forming openings. Themulti-part sealant can be mixed at any of a variety of ratios, dependingon the type of sealant used.

In other embodiments, the method can further include removing excesssealant from the anvil. This can be accomplished using a separatesqueegee or other scraping implement, or it can be accomplished in asingle pass if an applicator used to deposit the non-compressiblesealant includes a squeegee or scraper thereon.

In still other embodiments, the method can further include at leastpartially curing the non-compressible sealant after application to theanvil. Such a curing process can harden at least a portion of thenon-compressible sealant extending across the plurality of stapleforming openings, thereby assisting in retaining the non-compressiblesealant within the plurality of staple forming openings.

The devices and methods described herein can be utilized in a variety ofdifferent types of tissue throughout the body. Certain embodimentsdescribed herein can provide a more effective procedure for forming ananastomosis between two body lumens. Such a procedure is often employedwhen, for example, resecting a portion of a patient's colon.

A staple cartridge assembly for use with a surgical stapler is providedthat can include a cartridge body having a plurality of staple cavities,where each staple cavity has a surgical staple disposed therein. Theassembly can also include a plurality of sealing adjuncts coupled to thecartridge body such that a staple ejected from the cartridge body passesthrough one of the plurality of sealing adjuncts before entering intotissue adjacent to the cartridge body. Further, the plurality of staplecavities can be arranged such that a greater density of staple cavitiesis present at a proximal end and a distal end of the cartridge body thana density of staple cavities that is present in a middle portionextending between the proximal and distal ends. Further still, theplurality of sealing adjuncts can be positioned at the proximal anddistal ends of the cartridge body. Positioning the plurality of sealingadjuncts at a proximal and distal end of the cartridge body can keep thesealing adjuncts from interfering with operation of a circular staplerthat can resect tissue extending along the middle portion to form ananastomosis.

In some embodiments, however, the assembly can further include at leastone suture thread coupled to and extending between the plurality ofsealing adjuncts positioned at the proximal and distal ends of thecartridge body. Furthermore, to prevent interference of the at least onesuture thread with any staples ejected from the cartridge body, the atleast one suture thread can be offset from any staple cavity positionedin the middle portion of the cartridge body.

In other embodiments, the assembly can also include a washer disposedbetween the plurality of sealing adjuncts at the proximal and distalends of the cartridge body and coupled to the at least one suture threadextending therebetween. More particularly, in certain embodiments, afirst suture thread can extend between at least one sealing adjunct at aproximal end of the cartridge body and the washer, and a second suturethread can extend between the washer and at least one sealing adjunct ata distal end of the cartridge body. The first and second suture threadscan have identical or different lengths, depending on the particularembodiment employed.

The washer can be formed from a variety of materials and can have anumber of different sizes. In some embodiments, for example, the washercan be configured to elastically compress when the cartridge body iscompressed against tissue. In other embodiments, the washer can be rigidand the cartridge body can include a depression formed therein toaccommodate the washer during actuation of the surgical stapler. Instill other embodiments, a compressible washer can be utilized incombination with a cartridge body having a recess formed therein suchthat a required amount of elastic compression can be reduced.

Including a connecting suture thread and washer in the assembly canallow for complete resection of the staple line including the sealingadjuncts when forming an anastomosis, as described in more detail below.

In a further aspect, a surgical method is provided that can includetransecting a body lumen using a linear surgical stapler that delivers aplurality of sealing adjuncts in combination with a plurality ofsurgical staples at a proximal end and a distal end of a staple lineformed by the surgical stapler. Further, the plurality of sealingadjuncts positioned at the proximal and distal ends of the staple linecan be coupled to one another by at least one suture thread. The methodcan further include positioning a circular surgical stapler to create ananastomosis with a second body lumen across the staple line. The methodcan also include drawing the proximal and distal ends of the staple lineinto a central lumen of the circular stapler using the at least onesuture thread extending between the plurality of sealing adjunctspositioned at the proximal and distal ends of the staple line, andactuating the circular stapler to form the anastomosis and resect thestaple line.

In certain embodiments, the linear surgical stapler can also deliver awasher positioned at a mid-point between the proximal and distal ends ofthe staple line, and the washer can be coupled to the at least onesuture thread.

In some embodiments, positioning the circular stapler to create ananastomosis can include passing a stapler trocar across the staple lineand through the washer. Still further, in certain embodiments drawingthe proximal and distal ends of the staple line into the central lumenof the circular stapler can include retracting the stapler trocar andthe washer into the central lumen of the circular stapler. This canallow the circular stapler to completely resect the staple lineincluding the sealing adjuncts when forming the anastomosis, therebyreducing the possibility of future leakage through the staple lineformed by the linear surgical stapler.

In still other embodiments, positioning the circular stapler to createan anastomosis can further include mating an anvil to the stapler trocarsuch that the anvil prevents the stapler trocar from retracting throughthe washer. In such an embodiment, mating the anvil to the staplertrocar can trap the washer therebetween, such that retraction of thetrocar into the central lumen of the circular stapler will pull thewasher into the central lumen as well.

In another aspect, a surgical method is provided that can includetransecting a body lumen using a linear surgical stapler that delivers aplurality of sealing adjuncts in combination with a plurality ofsurgical staples at a proximal end and a distal end of a staple lineformed by the surgical stapler. Further, the plurality of sealingadjuncts positioned at the proximal and distal ends of the staple linecan be coupled to a washer positioned at a midpoint of the staple lineby a plurality of suture threads. The method can further includeextending a trocar out of a central lumen of a circular staplercartridge disposed within the body lumen such that the trocar crossesthe staple line and passes through the washer. The method can alsoinclude coupling the trocar to an anvil positioned in a second bodylumen such that a portion of the anvil receives the trocar and thewasher is trapped between the anvil and the trocar. The method canfurther include retracting the trocar into the central lumen of thecircular stapler cartridge to draw the anvil toward the circular staplerbody while simultaneously drawing the proximal and distal ends of thestaple line into the central lumen.

In certain embodiments, the method can also include actuating thecircular stapler cartridge to resect the staple line and form ananastomosis between the two body lumens. As described above, actuationcan resect the entirety of the staple line formed by the linear surgicalstapler because the proximal and distal ends of the staple line aredrawn into the central lumen of the circular stapler by their attachmentto the washer via the plurality of suture threads.

A surgical method is provided that in one embodiment includestransorally advancing a reinforcement material into a bronchial tube,and introducing a sealant into the bronchial tube and applying thesealant to the reinforcement material within the bronchial tube. Thesealant can transition from a first state to a second, harder statewithin the bronchial tube so as to secure the reinforcement material ina fixed position relative to the bronchial tube.

The method can vary in any number of ways. For example, advancing thereinforcement material can includes advancing a distal end of a scopingdevice into the bronchial tube and introducing the reinforcementmaterial into the bronchial tube through the scoping device. Introducingthe sealant can include introducing the sealant into the bronchial tubethrough the scoping device with the sealant in the first state. Foranother example, the method can include stapling the bronchial tube andthe reinforcement material that has been introduced into the bronchialtube. The sealant can be introduced and applied before the stapling ofthe bronchial tube and the reinforcement material, or the sealant can beintroduced and applied after the stapling of the bronchial tube and thereinforcement material. A first component of the sealant can beintroduced and applied before the stapling of the bronchial tube and thereinforcement material, and a second component of the sealant can beintroduced and applied after the stapling of the bronchial tube and thereinforcement material.

In another embodiment, a surgical method is provided that includespositioning a reinforcement material within a bronchial tube, staplingthe bronchial tube and the reinforcement material so as to form a stapleline extending across the bronchial tube, and applying a sealant to thereinforcement material within the bronchial tube. The sealant can movefrom a first state to a second, more rigid state within the bronchialtube so as to facilitate sealing of the staple line.

The method can have any number of variations. For example, the methodcan include expanding an inner diameter of the bronchial tube with aballoon while at least one of the reinforcement material is beingpositioned and the sealant is being applied. For another example, themethod can include, after positioning the reinforcement material andprior to the stapling, locating the reinforcement material within thebronchial tube by illuminating a light. For still another example, thereinforcement material can include at least one of a mesh, a non-wovenmatrix, a film, a melt-blown non-woven material, a felt material, aclosed-cell foam, an open-cell foam, a sponge, a braided suture,poliglecaprone, polyglactin, polydioxanone, collagen, oxidizedregenerated cellulose, regenerated cellulose, glycerol, glycolide,lactide, dioxanone, trimethylene carbonate, gut suture, polypropylene,polyethylene, polybutester fiber, stainless steel, nylon, polyester,silk, polyvinylidene difluoride, oxidized cellulose, and polypropylene.For another example, the sealant can include at least one of anadhesive, fibrin thrombin, a hydrogel, fibronectin, gelatin, collagen,Factor XIII, transglutaminase, Polyethylene glycol, alginate,carboxymethylcellulose, methylcellulose, hydroxypropylmethyl cellulose,pectin, polyvinyl alcohol, polyvinylpyrrolidone, benzocaine,cyanoacrylate, polyglycolic acid, hyaluronic acid, magnesium peroxide,2-octyl cyanoacrylate, and hydrogen peroxide. For yet another example,the method can include, after positioning the reinforcement material andprior to the stapling, locating the reinforcement material within thebronchial tube by positioning a magnet outside the bronchial tube. Themagnet can magnetically engage a target located within the bronchialtube adjacent to the reinforcement material. Positioning thereinforcement material can include introducing the reinforcementmaterial into the bronchial tube using a delivery device, the targetbeing attached to a distal end of the delivery device. The target caninclude one of a Hall sensor and a second magnet.

In another embodiment, a surgical method is provided that includespositioning a reinforcement material within a bronchial tube, andstapling the bronchial tube and the reinforcement material so as to forma staple line extending across the bronchial tube with the reinforcementmaterial engaged within the staple line. An actuator coupled to thereinforcement material can move from a first state to a second, harderstate after the stapling so as to facilitate sealing of the staple line.

The method can vary in any number of ways. For example, the method caninclude, after positioning the reinforcement material and prior to thestapling, locating the reinforcement material within the bronchial tubeby illuminating a light inside the bronchial tube. For another example,the reinforcement material can include at least one of a mesh, anon-woven matrix, a film, a melt-blown non-woven material, a feltmaterial, a closed-cell foam, an open-cell foam, a sponge, a braidedsuture, poliglecaprone, polyglactin, polydioxanone, collagen, oxidizedregenerated cellulose, regenerated cellulose, glycerol, glycolide,lactide, dioxanone, trimethylene carbonate, gut suture, polypropylene,polyethylene, polybutester fiber, stainless steel, nylon, polyester,silk, polyvinylidene difluoride, and polypropylene. For yet anotherexample, the actuator can include a biologic foam. For another example,the method can include, after positioning the reinforcement material andprior to the stapling, locating the reinforcement material within thebronchial tube by positioning a magnet outside the bronchial tube. Themagnet can magnetically engage a target located within the bronchialtube adjacent to the reinforcement material.

In one embodiment, a surgical kit is provided that includes a liquidsealant and a sealing cuff. The liquid sealant can be configured to cureinto a solidified state. The sealing cuff can have a sidewall with firstand second ends removably mated to one another to form an enclosed loop,and the sidewall can define an interior chamber. In use, the sealingcuff can be configured to be disposed around a body lumen such that theinterior chamber is sealed between the outer wall and the body lumen toallow the liquid sealant to be received therein and to directly contactthe body lumen. The surgical kit can further include a tube coupled tothe sealing cuff and configured to deliver the sealant to the interiorchamber of the sealing cuff.

The sealing cuff can vary in any number of ways. For example, thesidewall can be substantially hemispherical and an inner surface of thesidewall can be substantially concave. The sealing cuff can include aplurality of protrusions formed on inner surface of the sidewall forfacilitating distribution of the sealant within the interior chamber. Incertain aspects, the plurality of protrusions can be spaced evenly abouta circumference of the sidewall. For another example, the sealing cuffcan include sutures coupled to an inner surface of the sidewall. Incertain aspects, the sutures can be disposed in a criss-cross pattern.The sealing cuff can further include a locking mechanism for removablymating the first and second ends.

The surgical kit can further include at least one expandable memberconfigured to move from a compressed position to an expanded positionand having a shape that substantially corresponds to a shape of theinterior chamber of the sealing cuff when the at least one expandablemember is in the expanded position.

The sealant can also vary in a number of ways. For example, the sealantcan be selected from the group consisting of fibrin, thrombin, ahydrogel, benzocaine, cyanoacrylate, polyglycolic acid, hyaluronic acid,magnesium peroxide, hydrogen peroxide, platelet rich plasma, andcombinations thereof. In certain aspects, the sealant can be configuredto transition from the liquid to the solidified state after apredetermined amount of time.

A surgical device is provided that includes a sealing cuff having aring-shaped sidewall, the sidewall defining an interior chamberconfigured to hold a sealant therein. The sealing cuff can include aplurality of extensions for distributing the sealant within the interiorchamber, the plurality of extensions being sized and shaped such thatwhen the sealing cuff is disposed around a tubular body organ andsealant is delivered thereto, the sealant is distributing substantiallyuniformly in thickness within the interior chamber of the cuff andsolidifies substantially circumferentially around the organ.

The surgical device can vary in any number of ways. The sealing cuff canfurther include a port formed therein and configured to mate with adelivery tube for delivering a sealant to the interior chamber of thecuff. The plurality of extensions can vary in a number of ways. Forexample, each of the extensions can be disposed radially around thesealing cuff. For another example, the plurality of extensions can bespaced along an inner surface of the interior chamber. In certainaspects, the plurality of extensions can be substantiallycylindrical-shaped.

Methods for reinforcing an anastomosis of a tubular organ are alsoprovided and in one embodiment, the method can include forming ananastomosis in a tubular organ, applying a sealing cuff around theanastomosis, the sealing cuff including at least one strand of sutureextending along an inner surface of the sealing cuff and having a wovenstructure for containing a sealant, and injecting a sealant into aninterior chamber of the sealing cuff such that the sealant directlycontacts and forms a substantial seal around the anastomosis.

The method can be performed in various ways. In certain aspects, theanastomosis can be formed in the tubular organ prior to delivering thesealant into the interior chamber of the sealing cuff. In other aspects,the anastomosis can be formed in the tubular organ after the sealant isdelivered into the interior chamber of the sealing cuff Injecting thesealant into the interior chamber of the sealing cuff can cause thesealant to solidify around the at least one strand of suture. In certainaspects, after the sealant is solidified, the sealant can be releasedfrom the interior chamber of the cuff by detaching the at least onestrand of suture from the sealing cuff.

In one embodiment a surgical method, comprises affixing a first adjunctmaterial onto a tissue at a treatment site. A second adjunct material isapplied to at least a portion of the first adjunct material such thatthe second adjunct material interacts with the first adjunct material toform a seal in an area of the tissue covered by at least one of thefirst and the second adjunct material. In one aspect the step ofaffixing the first and/or the second adjunct is effected by stapling thefirst adjunct material to the tissue. At least one of the first andsecond adjunct materials is formed from biocompatible, absorbable suturematerial, selected from the group consisting of polydioxanon,Polyglycerol sebacate, Polyglycolic acid, Polycaprolactone, Polylacticacid, Polyhydroxyalkanoate, Poliglecaprone 25, polyglactin 910,polyglyconate, polyglocolide-trimethylene carbonate,polyhydroxybutyrate, poly(vinylpyrrolidone), poly(vinyl alcohol),absorbable polyurethanes, and regenerated cellulose. In one embodimentat least one of the first and second adjunct materials is oxidizedregenerated cellulose. At least one of the adjunct materials is made ofa bioabsorbable material or a biofragmentable material The first andsecond adjunct materials can be made of a single layer of material ormultiple layers, and one adjunct can be different from the other or thesame as the other. Further, either or both of the adjunct materials caninclude a therapeutic agent.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a side view of damaged stapled tissue;

FIG. 2 is a perspective view of one embodiment of an adjunct material asdescribed herein that is fixed to stapled tissue;

FIG. 3 is a perspective view of a prior art surgical instrument whichcan be used with one or more adjunct materials;

FIG. 4 is an exploded perspective view of an end effector and a distalend of a shaft of the instrument of FIG. 3;

FIG. 5 is a perspective view of an E-beam component of the instrument ofFIG. 3;

FIG. 6 is a perspective view of another prior art surgical instrumentwhich can be used with one or more adjunct materials;

FIG. 7 is a perspective view of another prior art surgical instrumentwhich can be used with one or more adjunct materials;

FIG. 8 is a perspective view of the end effector of FIG. 4;

FIG. 9 is a side view of a prior art end effector having an implantablestaple cartridge therein;

FIG. 10 is a side view of a prior art staple;

FIG. 11 is a cross-sectional view of the end effector of FIG. 9;

FIG. 12 is a top view of a prior art staple cartridge for use with theinstrument of FIG. 7;

FIG. 13 is a diagrammatic representation of lines of staples installedusing a prior art surgical stapling instrument;

FIG. 14 is a top view of a prior art staple cartridge having a staplepattern;

FIG. 15A is a side view of an end effector with a staple cartridgeloaded with an adjunct material;

FIG. 15B is a side, cross-sectional view of the end effector of FIG. 4having an adjunct material thereon;

FIG. 16A is a perspective view of adjunct material having a centralportion and a wing portion, the adjunct material being coupled to acartridge assembly;

FIG. 16B is a perspective view of an adjunct material stapled ontotissue;

FIG. 17 is a perspective view of another exemplary embodiment of adjunctmaterial stapled to tissue;

FIG. 18A is a perspective view of an adjunct material having edgeprotrusions configured to distribute a strain to tissue beyond a stapleline;

FIG. 18B is a perspective view of another adjunct material having edgeprotrusions, the adjunct material being stapled to tissue;

FIG. 19 is a perspective view of an adjunct material including an outerregion with a plurality of cuts formed therein;

FIGS. 20A-20C are side views of adjunct material having modified outerregions;

FIG. 20D is a side, cross-sectional view of adjunct material stapled toa body lumen;

FIG. 21A is a perspective view of adjunct material having first andsecond layers and woven, atraumatic edges;

FIG. 21B is a side view of the adjunct material of FIG. 21A showing thefirst and second layers;

FIG. 21C is a side view of the adjunct material of FIG. 21A absorbingfluid in between the first and second layers;

FIG. 22A is a perspective view of adjunct material having a variablethickness in a lateral direction;

FIG. 22B is an end view of an anvil and cartridge assembly and twovariable thickness adjuncts, a first adjunct material associated withthe anvil and a second adjunct material associated with the cartridgeassembly;

FIG. 22C is an end view of the anvil and cartridge assembly of FIG. 22Bhaving the first and second adjunct materials coupled thereto;

FIG. 22D is a side view of the first and second adjunct material stapledto tissue;

FIG. 23A is a side view of an adjunct material having surface featuresformed thereon for penetrating and gripping into tissue;

FIG. 23B is a side view of another adjunct material having surfacefeatures for penetrating and gripping into tissue;

FIG. 23C is an end view of four rows of adjunct material, each row ofadjunct material having a surface feature locked in a tissue;

FIG. 23D is a side view of an adjunct material having surface featurespenetrated into tissue;

FIG. 24A is a side view of another exemplary adjunct material having aplurality of pointed surface features for penetrating into tissue;

FIG. 24B is a side view of the adjunct material of FIG. 24A having thepointed surface features piercing into tissue;

FIG. 25A is a perspective view of a cartridge assembly having an adjunctmaterial for detachable coupling to a distal end of the cartridgeassembly;

FIG. 25B is a side view of the cartridge assembly and an anvil of asurgical stapler grasping tissue with the adjunct material of FIG. 25Aextending beyond a distal end of the cartridge assembly;

FIG. 25C is a side view of the cartridge assembly and the anvil of FIG.25B deploying staples through the adjunct material and the tissue;

FIG. 26A is a perspective view of adjunct material having protrusionsconfigured to mate with corresponding depressions formed in a cartridgeassembly;

FIG. 26B is a perspective view of adjunct material having a singleprotrusion configured to mate with a corresponding depression formed ina cartridge assembly;

FIG. 27A is an end view of an adjunct material extending around acartridge assembly and having first and second lateral edges coupled tothe cartridge assembly;

FIG. 27B is an end view of the adjunct material and the cartridgeassembly of FIG. 27A and a cutting member being advanced through thecartridge assembly to release the adjunct material from the cartridgeassembly;

FIG. 28A is a perspective view of a cartridge assembly including suturecoupling an adjunct material to the cartridge assembly;

FIG. 28B is a perspective view of the cartridge assembly and adjunctmaterial of FIG. 28A, the suture detached from the cartridge assembly torelease the adjunct material;

FIG. 29A is a perspective view of a shaft of a surgical staplerincluding an adjunct material coupled thereto;

FIG. 29B is a side view of the shaft of FIG. 29A showing attachmentpoints for attaching the adjunct material to the shaft;

FIG. 29C is a perspective view of a driver insertable within the shaftand having a plurality of lateral extension portions;

FIG. 29D is a perspective view of adjunct material for attaching to theshaft;

FIG. 29E is a partial top view of the shaft of FIG. 29A with a cuttingmember of the stapler in a first, retracted position;

FIG. 29F is a partial top view of the shaft of FIG. 29A with the cuttingmember in a second, advanced position that releases the adjunct materialfrom the shaft;

FIG. 30A is an end view of a cartridge assembly, an adjunct material,and an insertion tool for attaching the adjunct material to thecartridge assembly;

FIG. 30B is an end view of the insertion tool pressing the adjunctmaterial onto the cartridge assembly of FIG. 30A;

FIG. 30C is an end view of the cartridge assembly of FIG. 30A having theadjunct material attached thereto and after the insertion tool has beenremoved from the cartridge assembly;

FIG. 31A is an exemplary kit including a retaining tool and a surgicalstapler, the retaining tool being configured for wrapping the adjunctmaterial around a cartridge assembly/anvil;

FIG. 31B is a side view of the retaining tool of FIG. 31A being advancedproximally along a longitudinal axis of the anvil and the cartridgeassembly;

FIG. 31C is a perspective view of the retaining tool and stapler of FIG.31A, the retaining tool being in a proximal most position;

FIG. 32A is a perspective view of an end effector of a stapler having anadjunct material coupled thereto and positioned above a trocar;

FIG. 32B is a perspective view of the end effector of FIG. 32A havingthe adjunct material wrapped around the end effector as the end effectoris inserted through the trocar;

FIG. 33A is an end view of a cartridge assembly and an anvil of asurgical stapler having a multi-layer adjunct material coupled thereto;

FIG. 33B is a side view of three adjuncts stapled onto tissue and havingoverlapping portions therebetween;

FIG. 33C is a perspective view of a first adjunct material and a secondadjunct material stapled onto tissue and having first and secondoverlapping portions;

FIG. 34A is a perspective view of first and second adjunct materialsstapled onto tissue and having a sealant delivered onto an outer surfaceof the first adjunct;

FIG. 34B is a side view of the first and second adjunct materials ofFIG. 34A stapled to tissue;

FIG. 34C is a side view of the first and second adjunct materials ofFIG. 34A having sealant delivered to a space below an outer surface ofthe adjunct;

FIG. 34D is a side view of the first and second adjunct materials ofFIG. 34A in an expanded position;

FIG. 35A is a perspective view a system for nebulizing a sealant whichincludes a container and an applicator tool extending through a trocarand into a patient;

FIG. 35B is perspective view of the applicator tool of FIG. 35Adelivering sealant to a staple line in tissue;

FIG. 35C is a perspective view of the nebulized sealant of FIG. 35Ahardened onto the staple line;

FIG. 36A is a perspective view of another exemplary system fornebulizing a sealant and delivering a nebulized sealant to a patientdirectly through a trocar and into a patient; and

FIG. 36B is a perspective view of the trocar of FIG. 36A deliveringnebulized sealant onto tissue at and beyond the staple line;

FIG. 37A is a perspective view of a staple cartridge assembly comprisingan adjunct material, in accordance with some embodiments;

FIG. 37B is a cross-sectional view of a portion of the adjunct materialof FIG. 37A, in accordance with some embodiments;

FIG. 38 is a perspective, partially cut-away view of the adjunctmaterial, in accordance with some embodiments;

FIG. 39 is a perspective view of an interior hydrophilic, swellablematerial included in the adjunct material, in accordance with someembodiments;

FIG. 40 is a perspective view of the adjunct material before penetrationby surgical staples, in accordance with some embodiments;

FIG. 41A is a side view of tissue and adjunct materials retained to boththe cartridge assembly and anvil of a surgical stapler, afterpenetration by the surgical staples, in accordance with someembodiments;

FIG. 41B is another side view of tissue and adjunct materials retainedto both the cartridge assembly and anvil of a surgical stapler, afterpenetration by the surgical staples, in accordance with someembodiments;

FIG. 42A is a perspective view of the adjunct material includingportions of an outer material having different characteristics, inaccordance with some embodiments;

FIG. 42B is a side view of the adjunct material of FIG. 42A, inaccordance with some embodiments;

FIG. 43 is a perspective view of the adjunct material illustrating aperipheral edge portion of the adjunct material after penetration by thesurgical staples, in accordance with some embodiments;

FIG. 44 is a perspective view of the adjunct material of FIG. 43, inaccordance with some embodiments;

FIG. 45 is a perspective view of an adjunct material having a uniformthickness, in accordance with some embodiments;

FIG. 46 is a cross-sectional view of tissue and an anvil of a surgicalstapler having an adjunct material retained thereon, before penetrationof the tissue by surgical staples, in accordance with some embodiments;and

FIG. 47 is a side view of the tissue penetrated by the surgical staplesand the adjunct material penetrated and retained by surgical staples, inaccordance with some embodiments.

FIG. 48A is a perspective view of a woven adjunct material loaded onto acartridge assembly of a surgical stapler;

FIG. 48B is a top view of the woven adjunct material of FIG. 48A;

FIG. 48C is a side view of the woven adjunct material of FIG. 48Astapled onto tissue;

FIG. 49A is a side view of a woven adjunct material before a compressiveforce is applied thereto;

FIG. 49B is a side view of a woven adjunct material of FIG. 49A having acompressive force applied thereto;

FIG. 49C is a side view of the woven adjunct material of FIG. 49A afterthe compressive force is released therefrom;

FIG. 50 is a side view of one embodiment of a woven structure;

FIG. 51A is a side, cross-sectional view of a woven adjunct materialhaving outer support layers woven onto an elastic core layer;

FIG. 51B is a detailed view of the woven adjunct material of FIG. 51A;

FIG. 52A is a side view of the woven adjunct material of FIG. 51A incompressed state;

FIG. 52B is a side view of the woven adjunct material of FIG. 51A in anexpanded state;

FIG. 53A is a perspective view of an end effector with partial detail ofa fibrous adjunct material loaded onto the cartridge assembly;

FIG. 53B illustrates a fiber of the adjunct material of FIG. 53A coatedwith a drug.

FIG. 54A is a perspective view of a fleece adjunct material;

FIG. 54B is a perspective view of a longitudinal fleece adjunct materialwith a compressive force applied thereto.

FIG. 54C is a perspective view of a rectangular fleece adjunct materialwith a compressive force applied thereto.

FIG. 54D is a perspective view of a polygonal fleece adjunct materialwith a compressive force applied thereto.

FIG. 55 is a perspective view of an adjunct material that includes afleece core layer surrounded by woven support layers;

FIG. 56A is a perspective view of four adjunct materials for loadingonto an end effector of a stapler;

FIG. 56B is an end, sectional view of adjunct materials loaded onto boththe anvil and cartridge assembly of a stapler;

FIG. 57A is a front sectional view of adjunct materials loaded onto boththe anvil and cartridge assembly of an end effector;

FIG. 57B is a side sectional view of the adjunct material of FIG. 57Astapled onto tissue.

FIG. 58 is a top view of tissue damage that can occur near staple legs;

FIG. 59A is a side view of one embodiment of adjuncts coupled to astaple;

FIG. 59B is a side view of an alternative embodiment of adjuncts coupledto a staple;

FIG. 60 is a cross-sectional view of one embodiment of adjuncts coupledto a staple;

FIG. 61 is a perspective view of the adjuncts and staple of FIG. 60;

FIG. 62 is a cross-sectional view of the staple of FIG. 60 implanted intissue;

FIG. 63A is an illustration of one embodiment of adjunct operation innon-thoracic tissue;

FIG. 63B is an illustration of one embodiment of adjunct operation inthoracic tissue;

FIG. 64A is a side view of one embodiment of adjunct operation intissue;

FIG. 64B is a top view of the adjunct operation shown in FIG. 64A;

FIG. 65 is a perspective view of one embodiment of adjuncts coupled to astaple;

FIG. 66 is a perspective view of the staple of FIG. 65;

FIG. 67A is a side view of one embodiment of adjuncts coupled to astaple;

FIG. 67B is a side view of an alternative embodiment of adjuncts coupledto a staple;

FIG. 67C is a side view of still another alternative embodiment ofadjuncts coupled to a staple;

FIG. 68A is a cross-sectional view of the staple of FIG. 65 in a staplecartridge;

FIG. 68B is a cross-sectional view of the staple of FIG. 65 ejected intotissue;

FIG. 68C is a cross-sectional view of the adjuncts sealing the staple ofFIG. 65 in tissue;

FIG. 69A is a side view of an alternative embodiment of a staple;

FIG. 69B is a side view of an alternative embodiment of a staple;

FIG. 70 is a perspective view of an alternative embodiment of an adjunctcoupled to a staple;

FIG. 71A is a close perspective view of the adjunct of FIG. 70 beforeimplantation in tissue;

FIG. 71B is a close perspective view of the adjunct of FIG. 70 afterimplantation in tissue;

FIG. 72A is a side view of the staple of FIG. 70;

FIG. 72B is a cross-sectional view of the staple of FIG. 70 in tissue;

FIG. 73 is a perspective view of an alternative embodiment of an adjunctcoupled to a staple;

FIG. 74 is a side view of the staple of FIG. 73 in tissue;

FIG. 75 is a perspective view of still another alternative embodiment ofan adjunct coupled to a staple;

FIG. 76 is a perspective view of one embodiment of a staple cartridgehousing a plurality of staples having adjuncts coupled thereto;

FIG. 77 is a perspective view of an alternative embodiment of a staplecartridge housing a plurality of staples having adjuncts coupledthereto;

FIG. 78A is a top view of one embodiment of a staple cartridge ejectionslot that accommodates a staple having an adjunct coupled thereto;

FIG. 78B is a top view of an alternative embodiment of a staplecartridge ejection slot that accommodates a staple having an adjunctcoupled thereto;

FIG. 78C is a top view of still another alternative embodiment of astaple cartridge ejection slot that accommodates a staple having anadjunct coupled thereto;

FIG. 79 is a top view of one embodiment of a plurality of adjunctsegments coupled to one another;

FIG. 80 is a perspective view of an alternative embodiment of aplurality of adjunct segments;

FIG. 81A is a perspective view of one embodiment of a surgical endeffector having a plurality of adjunct segments accepting a vessel;

FIG. 81B is a perspective view of the surgical end effector of FIG. 81Astapling and transecting the vessel;

FIG. 81C is a perspective view of the vessel and adjuncts of FIG. 81Aafter transection;

FIG. 81D is a perspective view of the vessel and adjuncts of FIG. 81Aafter excess adjuncts are removed;

FIG. 82 is a perspective view of an alternative embodiment of aplurality of adjunct segments;

FIG. 83 is a perspective view of one embodiment of a surgical stapleranvil having a plurality of staple forming openings filled with aviscous sealant;

FIG. 84 is a perspective view of an alternative embodiment of a surgicalstapler anvil having a plurality of staple forming openings filled witha viscous sealant;

FIG. 85 is a cross-sectional view of one embodiment of a staple formingopening having a viscous sealant disposed therein and retained by afilm;

FIG. 86A is a cross-sectional view of one embodiment of a staple formingopening with a viscous sealant;

FIG. 86B is a cross-sectional view of the staple forming opening of FIG.86A prior to curing;

FIG. 86C is a cross-sectional view of the staple forming opening of FIG.86A after partial curing;

FIG. 86D is a cross-sectional view of the staple forming opening of FIG.86A after complete curing;

FIG. 87 is a side view of a surgical staple coupled to the adjunct ofFIG. 85;

FIG. 88 is a perspective view of one embodiment of a film connecting aplurality of adjuncts;

FIG. 89 is a perspective view of one embodiment of a weave connecting aplurality of adjuncts;

FIG. 90 is an exploded view of the weave and adjuncts of FIG. 89;

FIG. 91A is a perspective view of one embodiment of a plurality ofadjuncts coupled to one another by a film of cured adjunct material;

FIG. 91B is a perspective view of an alternative embodiment of aplurality of adjuncts separated from one another and including a layerof cured adjunct material;

FIG. 92 is a cross-sectional view of one embodiment of a staple in astaple cartridge, tissue, and an adjunct disposed in a staple formingopening of an anvil;

FIG. 93 is a cross-sectional view of a staple and the adjunct of FIG. 85disposed in tissue;

FIG. 94 is a cross-sectional view of the staple and adjunct of FIG. 93being cured after implantation in tissue;

FIG. 95 is a perspective view of one embodiment of a plurality ofadjuncts coupled by a plurality of connecting branches of adjunctmaterial;

FIG. 96 is an exploded view of the plurality of adjuncts of FIG. 95disposed in a plurality of staple forming openings of a surgical stapleranvil;

FIG. 97 is a perspective view of one embodiment of a surgical stapleranvil having features to destroy connecting branches extending between aplurality of adjuncts;

FIG. 98 is a cross-sectional view of one embodiment of a surgicalstapler including a staple disposed in a staple cartridge and aplurality of adjuncts coupled to the anvil of FIG. 97;

FIG. 99 is a cross-sectional view of the stapler of FIG. 98 ejecting astaple through tissue and into a staple forming opening of the anvil;

FIG. 100 is a cross-sectional view of the staple of FIG. 98 implanted intissue;

FIG. 101 is a perspective cross-sectional view of one embodiment of aretainer to hold adjunct material against a surgical stapler anvil;

FIG. 102A is a cross-sectional view of the retainer and anvil of FIG.101;

FIG. 102B is a cross-sectional view of an alternative embodiment of aretainer and anvil;

FIG. 103 is a cross-sectional view of one embodiment of a staple formingopening having a retainer formed thereon;

FIG. 104 is a cross-sectional view of the staple forming opening of FIG.103 holding adjunct material therein;

FIG. 105 is a top view of the staple forming opening of FIG. 103;

FIG. 106 is a perspective view of one embodiment of a surgical stapleranvil and staple cartridge having adjunct segments coupled thereto;

FIG. 107 is an exploded view of one embodiment of attachment andalignment features of a surgical stapler anvil;

FIG. 108 is a perspective view of the anvil of FIG. 107;

FIG. 109 is a perspective view of one embodiment of a surgical staplerhaving a plurality of adjunct segments coupled thereto and connected toone another by a film;

FIG. 110 is an exploded cross-sectional view of the surgical stapler ofFIG. 109;

FIG. 111 is a close cross-sectional view of a staple forming opening ofthe surgical stapler of FIG. 109;

FIG. 112 is a cross-sectional view of one embodiment of a plurality ofadjunct segments connected to one another by a film;

FIG. 113A is a cross-sectional view of the surgical stapler of FIG. 109prior to actuation;

FIG. 113B is a cross-sectional view of the surgical stapler of FIG. 109after actuation that delivers a staple into tissue;

FIG. 114A is a perspective view of one embodiment of a surgical staplerhaving a plurality of adjunct segments of differing thicknesses;

FIG. 114B is a close exploded view of the surgical stapler of FIG. 114A;

FIG. 115 is an exploded perspective view of an alternative embodiment ofa surgical stapler having a plurality of adjunct segments of differingthicknesses;

FIG. 116 is a cross-sectional view of the surgical stapler of FIG. 115;

FIG. 117 is a perspective view of an alternative embodiment of asurgical stapler having a plurality of adjunct segments of differingthicknesses;

FIG. 118A is an exploded view of one embodiment of a multi-materialadjunct;

FIG. 118B is a perspective view of the adjunct of FIG. 118A;

FIG. 119A is a perspective cross-sectional view of the adjunct of FIG.118A prior to actuation of a surgical stapler;

FIG. 119B is a perspective cross-sectional view of the adjunct of FIG.118A after actuation of a surgical stapler;

FIG. 120 is a cross-sectional view of one embodiment of a surgicalstaple and adjunct formed in tissue;

FIG. 121 is a cross-sectional view of an alternative embodiment of asurgical staple and adjunct formed in tissue;

FIG. 122 is a cross-sectional view of still another embodiment of asurgical staple and adjunct formed in tissue;

FIG. 123A is a top view of one embodiment of a plurality of adjunctscoupled to a surgical stapler anvil;

FIG. 123B is a top view of an alternative embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 123C is a top view of still another embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 123D is a top view of yet another embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 123E is a top view of still another embodiment of a plurality ofadjuncts coupled to a surgical stapler anvil;

FIG. 124 is a perspective view of one embodiment of a plurality ofadjuncts;

FIG. 125 is a top view of one embodiment of adjunct segment shapes;

FIG. 126 is a top view of the adjuncts of FIG. 125 coupled to oneanother;

FIG. 127 is a top view of one embodiment of a sheet of adjunct segmentscoupled to one another;

FIG. 128 is a top view of an alternative embodiment of adjunct segmentshapes;

FIG. 129 is a top view of the adjuncts of FIG. 128 coupled to oneanother;

FIG. 130A is a perspective view of one embodiment of adjunct segmentsextending between adjacent surgical staples;

FIG. 130B is a perspective view of an alternative embodiment of adjunctsegments extending between adjacent surgical staples;

FIG. 130C is a perspective view of another embodiment of adjunctsegments extending between adjacent surgical staples;

FIG. 131 is a perspective view of the adjuncts and surgical staples ofFIG. 130A disposed in tissue;

FIG. 132 is a cross-sectional view of the adjuncts and surgical staplesof FIG. 131;

FIG. 133 is a perspective view of an alternative embodiment of surgicalstaples and adjuncts in tissue;

FIG. 134 is a perspective view of another embodiment of surgical staplesand adjuncts in tissue;

FIG. 135 is a perspective view of still another embodiment of surgicalstaples and adjuncts in tissue;

FIG. 136 is a top view of one embodiment of surgical staples andadjuncts extending between adjacent staples;

FIG. 137 is a top view of an alternative embodiment of surgical staplesand adjuncts extending between adjacent staples;

FIG. 138A is a side view of the surgical staples and adjuncts of FIG.137 in a relaxed state;

FIG. 138B is a side view of the surgical staples and adjuncts of FIG.137 in a tensioned state;

FIG. 139 is a top view of one embodiment of surgical staples andadjuncts extending between adjacent staples;

FIG. 140A is a top view of an alternative embodiment of surgical staplesand adjuncts connected to one another by a serpentine carrier;

FIG. 140B is a side view of the surgical staples, adjuncts, andserpentine carrier of FIG. 140A;

FIG. 141A is a side view of one embodiment of an adjunct;

FIG. 141B is a front view of the adjunct of FIG. 141A;

FIG. 141C is a top view of the adjunct of FIG. 141A;

FIG. 141D is a perspective view of the adjunct of FIG. 141A;

FIG. 142A is a side view of an alternative embodiment of an adjunct;

FIG. 142B is a front view of the adjunct of FIG. 142A;

FIG. 142C is a top view of the adjunct of FIG. 142A;

FIG. 142D is a perspective view of the adjunct of FIG. 142A;

FIG. 143 is a side view of one embodiment of a plurality of adjunctscoupled to a backing material;

FIG. 144A is a side view of one embodiment of an adjunct;

FIG. 144B is a front view of the adjunct of FIG. 144A;

FIG. 144C is a top view of the adjunct of FIG. 144A;

FIG. 144D is a perspective view of the adjunct of FIG. 144A;

FIG. 145A is a side view of an alternative embodiment of an adjunct;

FIG. 145B is a front view of the adjunct of FIG. 145A;

FIG. 145C is a top view of the adjunct of FIG. 145A;

FIG. 145D is a perspective view of the adjunct of FIG. 145A;

FIG. 146 is an illustration of one embodiment of an adjunct applicator;

FIG. 147 is a cross-sectional view of the applicator of FIG. 146applying an adjunct to a surgical stapler anvil;

FIG. 148 is a side view of the applicator of FIG. 146 applying anadjunct to a surgical stapler anvil;

FIG. 149A is an illustration of an alternative embodiment of an adjunctapplicator;

FIG. 149B is an illustration of one embodiment of a squeegee that canremove excess adjunct applied to a surgical stapler;

FIG. 149C is a cross-sectional view of a surgical stapler anvil havingan adjunct applied thereto;

FIG. 150 is an illustration of one embodiment of a two-part adjunctapplicator;

FIG. 151 is an illustration of an alternative embodiment of a two-partadjunct applicator;

FIG. 152A is a cross-sectional view of one embodiment of an applicatornozzle coupled to an adjunct container;

FIG. 152B is a cross-sectional view of the applicator nozzle of FIG.152A piercing a seal formed on the adjunct container;

FIG. 153 is an illustration of the applicator of FIG. 150 applying anadjunct to a surgical stapler;

FIG. 154 is a side cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler;

FIG. 155 is a front cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler anvil;

FIG. 156 is a front cross-sectional view of one embodiment of anapplicator applying a two-part adjunct to a surgical stapler anvil;

FIG. 157 is a cross-sectional view of one embodiment of an adjunctdisposed within a staple forming opening of a surgical stapler anvil;

FIG. 158 is a front cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler cartridge;

FIG. 159 is a front cross-sectional view of one embodiment of anapplicator applying an adjunct to a surgical stapler cartridge;

FIG. 160 is a cross-sectional view of one embodiment of an adjunctdisposed within a surgical stapler cartridge cavity;

FIG. 161 is a cross-sectional view of one embodiment of a surgicalstaple formed within tissue;

FIG. 162 is an illustration of one embodiment of an adjunct applicatorand surgical stapler;

FIG. 163 is a cross-sectional view of one embodiment of a surgicalstaple formed so as to trap adjunct material;

FIG. 164A is an illustration of one embodiment of a surgical staplerpositioned to transect tissue;

FIG. 164B is an illustration the tissue of FIG. 164A transected withstaples and adjunct segments coupled thereto;

FIG. 164C is an illustration of the surgical stapler of FIG. 164A havingexcess staples and adjuncts coupled thereto;

FIG. 165 is an illustration of one embodiment of a non-continuousadjunct for use in forming an anastomosis;

FIG. 166 is an illustration of one embodiment of a surgical staplercartridge for use with the adjunct of FIG. 165;

FIG. 167 is an illustration of one embodiment of a staple pattern foruse with the adjunct of FIG. 165;

FIG. 168 is an illustration of an alternative embodiment of anon-continuous adjunct for use in forming an anastomosis;

FIG. 169 is an illustration of one embodiment of a surgical staplercartridge for use with the adjunct of FIG. 168;

FIG. 170 is an exploded view of the adjunct of FIG. 168 and surgicalstapler cartridge of FIG. 169;

FIG. 171 is an illustration of one embodiment of a staple pattern andthe adjunct of FIG. 168;

FIG. 172 is an exploded view of the surgical stapler cartridge of FIG.169 and the adjunct of FIG. 171;

FIG. 173 is an illustration of the surgical stapler cartridge of FIG.169 and the adjunct of FIG. 171;

FIG. 174 is a cross-sectional view of one embodiment of an adjunctwasher before and during actuation of a surgical stapler;

FIG. 175 is an illustration of one embodiment of a surgical staplercartridge for use in forming an anastomosis;

FIG. 176 is an illustration of one embodiment of a body lumen transectedby a surgical stapler;

FIG. 177A is a cross-sectional view of a staple line including anadjunct with a washer;

FIG. 177B is a cross-sectional view of a circular stapler trocaradvancing toward the staple line of FIG. 177A;

FIG. 177C is a cross-sectional view of the circular stapler trocar ofFIG. 177B crossing the staple line of FIG. 177A;

FIG. 178 is an illustration of a circular stapler trocar passing througha washer of the non-continuous adjunct of FIG. 175;

FIG. 179 is an illustration of a circular stapler anvil being positionedover the circular stapler trocar of FIG. 177B;

FIG. 180 is an illustration of an alternative embodiment of a circularstapler anvil being positioned over the circular stapler trocard of FIG.177B;

FIG. 181 is a cross-sectional view of one embodiment of a circularstapler anvil trapping an adjunct washer over a circular stapler trocar;

FIG. 182 is a close cross-sectional view of the circular stapler anvil,adjunct washer, and circular stapler trocar of FIG. 181;

FIG. 183 is a cross-sectional view of the circular stapler trocar ofFIG. 181 being withdrawn into a central lumen of the circular stapler;

FIG. 184 is an illustration of one embodiment of forces exerted on anon-continuous adjunct upon withdrawal of a circular stapler trocarcoupled thereto;

FIG. 185 is a cross-sectional view of the circular stapler of FIG. 181being actuated to resect the staple line including the non-continuousadjunct; and

FIG. 186 is a cross-sectional view of an anastomosis produced byactuation of the circular stapler of FIG. 181.

FIG. 187 is a perspective, partially transparent view of a patient withone embodiment of a surgical instrument transorally advanced into abronchial tube of the patient;

FIG. 188 is an exploded perspective view of a distal end of the surgicalinstrument of FIG. 187 including a scoping device and an end cap;

FIG. 189 is a perspective, partially cross-sectional view of the scopingdevice of FIG. 188 advanced into the bronchial tube of FIG. 187, oneembodiment of a grasper advanced through a working channel of thescoping device and grasping one embodiment of a reinforcement material,and one embodiment of a stapler having a distal end positioned outsideand adjacent to the bronchial tube;

FIG. 190 is a perspective, partially cross-sectional view of the staplerof FIG. 189 stapling the bronchial tube and the reinforcement material;

FIG. 191 is a perspective, partially cross-sectional view of the scopingdevice of FIG. 188, with the end cap of FIG. 188 attached thereto,within a portion of the bronchial tube of FIG. 190 stapled and cut bythe stapler, and one embodiment of an applicator advanced through theworking channel of the scoping device and a working port of the end cap,the applicator applying one embodiment of a sealant, the sealant beingin a first state;

FIG. 192 is a perspective, partially cross-sectional view of the scopingdevice and the end cap of FIG. 6 being removed from the bronchial tubewith the applied sealant being in a hardened state;

FIG. 193 is a perspective, partially cross-sectional view of the scopingdevice of FIG. 188 disposed within a bronchial tube and the grasper ofFIG. 189 advanced through the working channel of the scoping device andgrasping another embodiment of a reinforcement material coupled toanother embodiment of a sealant;

FIG. 194 is a perspective, partially cross-sectional view of the staplerof FIG. 189 stapling the bronchial tube, the reinforcement material, andthe sealant of FIG. 193;

FIG. 195 is a perspective, partially transparent view of another patientwith another embodiment of a surgical instrument transorally advancedinto a bronchial tube of the patient;

FIG. 196 is a perspective view of another embodiment of a stapler withjaws thereof positioned on either side of the bronchial tube of FIG.195;

FIG. 197 is a perspective view of the bronchial tube of FIG. 196 afterbeing stapled and cut by the stapler;

FIG. 198 is a perspective, partially transparent view of the instrumentof FIG. 195 advanced into the stapled and cut bronchial tube of FIG. 197with a distal end of the instrument positioned adjacent a stapled andcut end of the bronchial tube;

FIG. 199 is another perspective view of the distal end of the instrumentof FIG. 198 positioned adjacent the stapled and cut end of the bronchialtube;

FIG. 200 is a side, cross-sectional view of the stapled and cut end ofthe bronchial tube of FIG. 199 having another embodiment of a sealantdisposed therein, the sealant having been advanced into the bronchialtube from the instrument; and

FIG. 201 is a side, cross-sectional view of the and cut end of thebronchial tube of FIG. 200 having another embodiment of a reinforcementmaterial and additional sealant disposed therein, the reinforcementmaterial and the additional sealant having been advanced into thebronchial tube from the instrument.

FIG. 202A is a perspective view of a sealing cuff, according to oneexemplary embodiment;

FIG. 202B is a side view of the sealing cuff of FIG. 202A;

FIG. 202C is a cross-sectional view of the sealing cuff of FIG. 202A;

FIG. 203 is another embodiment of a sealing cuff having one or moreextension ports that facilitate positioning the cuff around a bodylumen;

FIG. 204A is a partial, cross-sectional view of a sealing cuff havingsuture woven across an inner surface thereof for contacting a sealant;

FIG. 204B is partial, side view of the sealing cuff of FIG. 204A showinga passageway formed in a wall of the cuff and having suture extendingtherethrough;

FIG. 205A is an exemplary embodiment of a foamed sealant;

FIG. 205B is a side view of the foamed sealant of FIG. 205A penetratinginto an anastomosis;

FIG. 206A is a side view of an expandable device including first andsecond expandable members;

FIG. 206B is a side view of another embodiment of an expandable devicehaving first and second expandable members;

FIG. 206C is a side view of an expandable device having a singleexpandable member;

FIG. 206D is a side view of another embodiment of an expandable devicehaving a single expandable member;

FIG. 207 is a side view of an expandable device having a lumen fordelivering fluid to a space between first and second expandable members;

FIG. 208A is a side view of one embodiment of a stent having first andsecond expandable portions;

FIG. 208B is a side view of another embodiment of a stent having firstand second expandable portions;

FIG. 208C is a side view of yet another embodiment of a stent havingfirst and second expandable portions;

FIG. 209A is a perspective view of the sealing cuff of FIG. 202A beingpositioned over a first section of a tubular body organ;

FIG. 209B is a perspective view of a trocar having a tool extendingtherethrough and into a positioning port formed on the sealing cuff;

FIG. 209C is a cross-sectional view of the organ of FIG. 209A showing ananvil and cartridge assembly of a surgical stapler, the anvil positionedinside of the first section of the tubular organ and the cartridgeassembly positioned inside of the second section of the tubular organ;

FIG. 209D is a cross-sectional view of the stapler and tubular organ ofFIG. 209A, the anvil moved toward the cartridge assembly and deployingstaples to form the anastomosis as the sealing cuff is positioned awayfrom the anastomosis;

FIG. 209E is a cross-sectional view of the sealing cuff of FIG. 209Aillustrating the cuff's direction of movement along the tubular organand toward the anastomosis;

FIG. 209F is a cross-sectional view of the sealing cuff of FIG. 209Ashowing sealant being delivered to the sealing cuff and into theanastomosis;

FIG. 209G is a perspective view of the sealing cuff of FIG. 209A beingremoved from the tubular organ after the sealant has cured around theanastomosis;

FIG. 210A is a perspective, semi-transparent view of an anvil of acircular stapler positioned inside of a tubular organ;

FIG. 210B is a side, semi-transparent view of the anvil and tubularorgan of FIG. 210A, the anvil having first and second expandable memberscoupled thereto;

FIG. 210C is a side, semi-transparent view of the tubular organ of FIG.10B formed into an anastomosis and having the first and secondexpandable members coupled to a scope;

FIG. 210D is a side, semi-transparent view of the first expandablemember positioned proximal to the anastomosis, in an expanded position;

FIG. 210E is a side, semi-transparent view of the first and secondexpandable members disposed on opposite sides of the anastomosis, intheir expanded positions;

FIG. 211A is a perspective view of an expandable member disposed on ascope, the scope extending through an anus and moving toward the sealingcuff;

FIG. 211B is a partial cross-sectional view of the tubular organ havingthe scope of FIG. 211A extending therethrough, the expandable memberbeing in a first, compressed position adjacent to the anastomosis and tothe sealing cuff;

FIG. 211C is a partial cross-sectional view of the tubular organ of FIG.211B showing the expandable member in a second, expanded position;

FIG. 212A is a partial cross-sectional view of an anastomosis of atubular organ, along with a scope having a tether coupled thereto thatis attached to a first expandable member;

FIG. 212B is a partial cross-sectional view of the first expandablemember being positioned proximal to the anastomosis as a terminal end ofthe tether is positioned outside of the patient's body;

FIG. 212C is a partial cross-sectional view of the first expandablemember being inflated to an expanded position and the second expandablemember being positioned over the tether;

FIG. 212D is a partial cross-sectional view of the second expandablemember moving toward the anastomosis in a compressed position;

FIG. 212E is a partial cross-sectional view of showing the secondexpandable member being inflated to an expanded position through itsinflation lumen;

FIG. 213 is a cross-sectional view of a first and second expandablemembers forming a seal inside of the tubular organ and gas beingdelivered to the sealed space between the expandable members so as totest leakage from the anastomosis;

FIG. 214A is a cross-sectional view of another embodiment of first andsecond expandable members with gas delivered to a space therebetween soas to test leakage from the anastomosis; and

FIG. 214B is a cross-sectional view of an embodiment of an expandablemember having a central portion configured to support the anastomosis asfluid is delivered to the space adjacent to the anastomosis so as totest leakage therefrom.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of such devices and methods is defined solely by the claims.The features illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the devices and methods described herein. Further, in thepresent disclosure, like-numbered components of the various embodimentsgenerally have similar features when those components are of a similarnature and/or serve a similar purpose.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment,” or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment,” or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the methods, apparatus, devices, andsystems described herein.

Additionally, to the extent that linear or circular dimensions are usedin the description of the disclosed systems, devices, and methods, suchdimensions are not intended to limit the types of shapes that can beused in conjunction with such systems, devices, and methods. A personskilled in the art will recognize that an equivalent to such linear andcircular dimensions can easily be determined for any geometric shape.Sizes and shapes of the systems and devices, and the components thereof,can depend at least on the anatomy of the subject in which the systemsand devices will be used, the size and shape of components with whichthe systems and devices will be used, and the methods and procedures inwhich the systems and devices will be used.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

It can be desirable to use one or more biologic materials and/orsynthetic materials, collectively referred to herein as “adjunctmaterials,” in conjunction with surgical instruments to help improvesurgical procedures. These biologic materials may be derived from humanand/or animal sources. A person skilled in the art may refer to thesetypes of materials as buttress materials as well as adjunct materials.

Various exemplary devices and methods are provided for performingsurgical procedures. In some embodiments, the devices and methods areprovided for open surgical procedures, and in other embodiments, thedevices and methods are provided for laparoscopic, endoscopic, and otherminimally invasive surgical procedures. The devices may be fireddirectly by a human user or remotely under the direct control of a robotor similar manipulation tool. However, a person skilled in the art willappreciate that the various methods and devices disclosed herein can beused in numerous surgical procedures and applications. Those skilled inthe art will further appreciate that the various instruments disclosedherein can be inserted into a body in any way, such as through a naturalorifice, through an incision or puncture hole formed in tissue, orthrough an access device, such as a trocar cannula. For example, theworking portions or end effector portions of the instruments can beinserted directly into a patient's body or can be inserted through anaccess device that has a working channel through which the end effectorand elongated shaft of a surgical instrument can be advanced.

End effectors of the surgical instruments as described herein can beconfigured to deliver one or more synthetic materials and/or biologicmaterials, collectively referred to herein as “adjunct materials,” to asurgical site to help improve surgical procedures. These biologicmaterials may be derived from human and/or animal sources. While avariety of different end effectors can benefit from the use of adjunctmaterials, in some exemplary embodiments the end effector can be asurgical stapler. When used in conjunction with a surgical stapler, theadjunct material(s) can be disposed between and/or on jaws of thestapler, incorporated into a staple cartridge disposed in the jaws, orotherwise placed in proximity to the staples. When staples are deployed,the adjunct material(s) can remain at the treatment site with thestaples, in turn providing a number of benefits. In some instances, theadjunct material(s) can be used to help seal holes formed by staples asthey are implanted into tissue, blood vessels, and various other objectsor body parts, and/or can be used to provide tissue reinforcement at thetreatment site. Tissue reinforcement may be needed to keep the staplesfrom tearing through the tissue if the tissue is diseased, is healingfrom another treatment such as irradiation, medications such aschemotherapy, or other tissue property altering situation. In someinstances, the adjunct material(s) may minimize tissue movement in andaround the staple puncture sites that can occur from tissue deformationthat occurs after stapling (e.g., lung inflation, gastrointestinal tractdistension, etc.). It will be recognized by one skilled in the art thata staple puncture site may serve as a stress concentration and that thesize of the hole created by the staple will grow when the tissue aroundit is placed under tension. Restricting the tissues movement aroundthese puncture sites can minimize the size the holes may grow to undertension. In some instances, the adjunct material(s) can be configured towick or absorb beneficial fluids, e.g., sealants, blood, glues, thatfurther promote healing, and in some instances, the adjunct material(s)can be configured to degrade to form a gel, e.g., a sealant, thatfurther promotes healing. In some instances, the adjunct may carrymaterials that when placed into a wet environment (e.g., blood, water,saline, or other bodily fluids) form a sealant to create a seal (e.g.,human or animal derived fibrinogen and thrombin can be lyophilized intoa powder form that when mixed with water creates a sealant). Stillfurther, the material(s) can help reduce inflammation, promote cellgrowth, and otherwise improve healing.

FIG. 2 illustrates one embodiment of an adjunct material that includes aporous buttress 30 that can be fixed to a tissue T to be treated by asurgical stapler and that remains at the treatment site with staples 70.The buttress 30 can be made from one or more absorbent materials and canbe stamped, pressed, cut, molded, woven, melted, blown, comprised fromcomposite structures and/or methods or otherwise shaped to facilitateabsorption, reinforcement, delivery and/or retention of beneficialfluids such as sealants, glues, blood, etc. The absorption and/orretention of beneficial fluids, for example a fibrin sealant 40, at thetreatment site can further help to prevent leaks and to reinforce thebuttress 30.

In use, the adjunct material can come pre-loaded onto the device and/orthe staple cartridge, while in other instances the adjunct material canbe packaged separately. In instances in which the adjunct material comespre-loaded onto the device and/or the staple cartridge, the staplingprocedure can be carried out as known to those skilled in the art. Forexample, in some instances the firing of the device can be enough todisassociate the adjunct material from the device and/or the staplecartridge, thereby requiring no further action by the clinician. Inother instances any remaining connection or retention member associatingthe adjunct material with the device and/or the staple cartridge can beremoved prior to removing the instrument from the surgical site, therebyleaving the adjunct material at the surgical site. In instances in whichthe adjunct material is packaged separately, the material can bereleasably coupled to at least one of a component of the end effectorand the staple cartridge prior to firing the device. The adjunctmaterial may be refrigerated, and thus removed from the refrigerator andthe related packaging, and then coupled to the device using a connectionor retention member as described herein or otherwise known to thoseskilled in the art. The stapling procedure can then be carried out asknown to those skilled in the art, and if necessary, the adjunctmaterial can be disassociated with the device as described above.

A person skilled in the art will recognize a variety of other ways bywhich the adjunct material can be temporarily retained with respect tothe end effector. In various embodiments a connection or retentionmember can be configured to be released from an end effector anddeployed along with a piece of adjunct material. In at least oneembodiment, head portions of retention members can be configured to beseparated from body portions of retention members such that the headportions can be deployed with the adjunct material while the bodyportions remain attached to the end effector. In other variousembodiments, the entirety of the retention members can remain engagedwith the end effector when the adjunct material is detached from the endeffector.

Adjunct materials described herein may be used in any surgery where asurgical stapler or other instrument creating tissue punctures isutilized. In some embodiments, adjunct materials described herein may beused for sealing staple punctures created when a surgical stapler isused in lung surgery. When surgery is performed on a lung (e.g.,lobectomy, segmentectomy, wedge resection, lung volume reductionsurgery, etc.), the lung is typically collapsed, and the requiredprocedure, including application of the stapler to tissue to be removed,is then performed on the collapsed lung. After the procedure iscompleted, the collapsed lung is re-inflated. The re-inflation of thelung stretches the lung parenchyma, which may result in increased stressat a junction between the stapled tissue and surrounding tissue that wasnot punctured. Furthermore, airtight sealing is required for the staplepunctures of the lung. Such airtight sealing may be difficult to achievedue to lung tissue movement. While leaks around staple puncturestypically heal within approximately five days, in some cases, staplepunctures may persist for longer periods of time, such as, for example,up to six months.

Accordingly, some embodiments provide adjunct material that may be usedto seal staple punctures created by a surgical stapler used to securelung tissue. However, it should be appreciated that the adjunctmaterials can also be used to seal punctures created by surgicalstaplers used to secure any other type of tissue, such as, for example,blood vessels, intestinal, stomach and esophageal tissue.

Various exemplary sealants and methods of sealing a tubular body organare provided herein. In general, the sealants can facilitate sealingaround a stapled body lumen, such as around a colon or around anintestinal anastomosis. A sealant can be formulated in various ways andcan have various properties, but is generally provided in a first,liquid state and then cures to a second, solidified state after apredetermined amount of time. For example, the sealant can be introducedto the tubular body organ and can help reinforce a seal at the stapleline of an anastomosis. When the sealant is in its liquid state, thesealant can seep into the staple line and can solidify therein, therebyfacilitating a complete sealing of the tubular body organ at the stapleline. The sealant can facilitate short term sealing of the tubular bodyorgan and can be formulated so that it is absorbed into the body afterthe tubular body organ has healed at the anastomosis. In certainaspects, a sealing cuff is provided that can act as a mold or form forholding the sealant at the desired location, e.g. adjacent to a stapleline, when the sealant is in the first, liquid state. One or moreexpandable members can be configured to expand the tubular body organ tofurther maintain contact between the sealant and the sealing cuff. Inthis way, the sealing cuff can be configured to hold the sealant at thedesired location so that the sealant is more likely to completely sealthe staple line and remain sealed as liquid and solid material passesthrough the tubular body organ during normal bodily functions.

The method can be performed in various ways. For example, at least oneexpandable member can be inserted into the tubular organ within ananastomosis. The expandable member can be inserted in a first,compressed position and can be moved to a second, expanded position toincrease a diameter of a portion of the tubular organ. In general, oneor more expandable members can be positioned adjacent to the staple lineso that the tissue surrounding the staple line can be expanded. Asealing cuff can be positioned around an outer surface of the tubularorgan and around the staple line. When the expandable member isexpanded, the tissue can move toward the sealing cuff. The sealant canbe predisposed within or introduced into the sealing cuff to reinforce aseal at the staple line of the anastomosis. A method for conducting aleak test of an anastomosis is also provided and can be performed beforeor after a sealant is applied thereto allow a surgeon to visuallyidentify whether there are openings between the tissue and the stapleline during expansion and contraction of the organ. Liquid or gas can bedelivered into the organ using various techniques and visualizationtechniques can be used to allow a user can visually identify whether theliquid/gas is leaking out of the organ through the staple line. This canhelp a user determine whether sealant should be applied to reinforce thetissue during the surgical procedure, or if sealant has already beenapplied, whether additional sealant or other sealing techniques shouldbe used to reinforce the seal. As described further below, the sealingcuff and expandable member(s) can be used in conjunction with the leaktest, such as to reinforce the tissue after a user identifies leakagethrough the anastomosis.

Surgical Stapling Instrument

While a variety of surgical instruments can be used in conjunction withthe adjunct materials disclosed herein, FIG. 3 illustrates one,non-limiting exemplary embodiment of a surgical stapler 10 suitable foruse with one or more adjunct materials. The instrument 10 generallyincludes a handle assembly 12, a shaft 14 extending distally from adistal end 12 d of the handle assembly 12, and an end effector 50 at adistal end 14 d of the shaft 14. Because the illustrated embodiment is asurgical stapler, the end effector 50 has jaws 52, 54, although othertypes of end effectors can be used with the shaft 14, handle assembly12, and components associated with the same. The surgical stapler 10includes opposed lower and upper jaws 52, 54 with the lower jaw 52including a staple channel 56 (FIG. 4) configured to support a staplecartridge 60, and the upper jaw 54 having an inner surface 58 that facesthe lower jaw 52 and that is configured to operate as an anvil to helpdeploy staples 70 of the staple cartridge 60. The jaws 52, 54 areconfigured to move relative to one another to clamp tissue or otherobjects disposed therebetween, and components of a firing system can beconfigured to pass through at least a portion of the end effector 50 toeject the staples into the clamped tissue. In various embodiments aknife blade 81 can be associated with the firing system to cut tissueduring the stapling procedure. At least one of the opposed lower andupper jaws 52, 54 will be moveable relative to the other lower and upperjaws 52, 54. At least one of the opposed lower and upper jaws 52, 54 maybe fixed or otherwise immovable. In some embodiments, both of theopposed lower and upper jaws 52, 54 will be movable.

Operation of the end effector 50 can begin with input from a clinicianat the handle assembly 12. The handle assembly 12 can have manydifferent configurations designed to manipulate and operate the endeffector 50 associated therewith. In the illustrated embodiment, thehandle assembly 12 has a pistol-grip type housing 18 with a variety ofmechanical and/or electrical components disposed therein to operatevarious features of the instrument. For example, the handle assembly 12can include a rotation knob 26 mounted adjacent a distal end 12 dthereof which can facilitate rotation of the shaft 14 and/or the endeffector 50 with respect to the handle assembly 12 about a longitudinalaxis L of the shaft 14. The handle assembly 12 can further includeclamping components as part of a clamping system actuated by a clampingtrigger 22 and firing components as part of the firing system that areactuated by a firing trigger 24. The clamping and firing triggers 22, 24can be biased to an open position with respect to a stationary handle20, for instance by a torsion spring. Movement of the clamping trigger22 toward the stationary handle 20 can actuate the clamping system,described below, which can cause the jaws 52, 54 to collapse towardseach other and to thereby clamp tissue therebetween. Movement of thefiring trigger 24 can actuate the firing system, described below, whichcan cause the ejection of staples from a staple cartridge disposedtherein and/or the advancement the knife blade 81 to sever tissuecaptured between the jaws 52, 54. A person skilled in the art willrecognize that various configurations of components for a firing system,mechanical, hydraulic, pneumatic, electromechanical, robotic, orotherwise, can be used to eject staples and/or cut tissue, and thus adetailed explanation of the same is unnecessary.

As shown in more detail in FIG. 4, the end effector 50 of theillustrated embodiment is a surgical stapling tool having a lower jaw 52that serves as a cartridge assembly or carrier and an opposed upper jaw54 that serves as an anvil. The staple cartridge 60, having a pluralityof staples 70 therein, is supported in a staple tray 57, which in turnis supported within the cartridge channel of the lower jaw 52. The upperjaw 54 has a plurality of staple forming pockets 66 (FIG. 11), each ofwhich is positioned above a corresponding staple from the plurality ofstaples 70 contained within the staple cartridge 60. The upper jaw 54can be connected to the lower jaw 52 in a variety of ways, although inthe illustrated embodiment the upper jaw 54 has a proximal pivoting end54 p that is pivotally received within a proximal end 56 p of the staplechannel 56, just distal to its engagement to the shaft 14. When theupper jaw 54 is pivoted downwardly, the upper jaw 54 moves the anvilsurface 58 and the staple forming pockets 66 formed thereon move towardthe opposing staple cartridge 60.

Various clamping components can be used to effect opening and closing ofthe jaws 52, 54 to selectively clamp tissue therebetween. In theillustrated embodiment, the pivoting end 54 p of the upper jaw 54includes a closure feature 54 c distal to its pivotal attachment withthe staple channel 56. Thus, a closure tube 82, whose distal endincludes a horseshoe aperture 82 a that engages the closure feature 54c, selectively imparts an opening motion to the upper jaw 54 duringproximal longitudinal motion and a closing motion to the upper jaw 54during distal longitudinal motion of the closure tube 82 in response tothe clamping trigger 22. It will be appreciated by a person skilled inthe art that opening and closure of the end effector 50 may be effectedby relative motion of the lower jaw 52 with respect to the upper jaw 54,relative motion of the upper jaw 54 with respect to the lower jaw 52, orby motion of both jaws 52, 54 with respect to one another.

The firing components of the illustrated embodiment can include a firingbar 84, as shown in FIG. 5, having an E-beam 86 on a distal end thereof.The firing bar 84 is encompassed within the shaft 14, for example in alongitudinal firing bar slot 14 s of the shaft 14, and guided by afiring motion from the handle 12. Actuation of the firing trigger 24 canaffect distal motion of the E-beam 86 through at least a portion of theend effector 50 to thereby cause the firing of staples 70 containedwithin the staple cartridge 60. In the illustrated embodiment, guides 85projecting from a distal end of the E-Beam 86 can engage a wedge sled90, which in turn can push staple drivers 92 upwardly through staplecavities 68 formed in the staple cartridge 60. Upward movement of thestaple drivers 92 applies an upward force on each of the plurality ofstaples 70 within the cartridge 60 to thereby push the staples 70upwardly against the anvil surface 58 of the upper jaw 54 and to createformed staples 70′.

In addition to causing the firing of staples, the E-beam 86 can beconfigured to facilitate closure of the jaws 52, 54, spacing of theupper jaw 54 from the staple cartridge 60, and/or severing of tissuecaptured between the jaws 52, 54. In particular, a pair of top pins 87and a pair of bottom pins 89 can engage one or both of the upper andlower jaws 52, 54 to compress the jaws 52, 54 toward one another as thefiring bar 84 advances through the end effector 50. Simultaneously, aknife 81 extending between the top and bottom pins 87, 89 can beconfigured to sever tissue captured between the jaws 52, 54.

In use, the surgical stapler 10 can be disposed in a cannula or port anddisposed at a surgical site. A tissue to be cut and stapled can beplaced between the jaws 52, 54 of the surgical stapler 10. Features ofthe stapler 10 can be maneuvered as desired by the clinician to achievea desired location of the jaws 52, 54 at the surgical site and thetissue with respect to the jaws 52, 54. After appropriate positioninghas been achieved, the clamping trigger 22 can be pulled toward thestationary handle 20 to actuate the clamping system. The trigger 22 cancause components of the clamping system to operate such that the closuretube 82 advances distally through at least a portion of the shaft 14 tocause at least one of the jaws 52, 54 to collapse towards the other toclamp the tissue disposed therebetween. Thereafter, the trigger 24 canbe pulled toward the stationary handle 20 to cause components of thefiring system to operate such that the firing bar 84 and/or the E-beam86 are advanced distally through at least a portion of the end effector50 to effect the firing of staples 70 and optionally to sever the tissuecaptured between the jaws 52, 54.

Another embodiment of a surgical instrument 100 is illustrated in FIG.6. Like surgical instrument 10, surgical instrument 100 includes ahandle assembly 112 with a shaft 114 extending distally therefrom andhaving an end effector 150 on a distal end thereof for treating tissue.Upper and lower jaws 154, 152 of the end effector 150 can be configuredto capture tissue therebetween, staple the tissue by firing of staplesfrom a cartridge 160 disposed in the lower jaw 154, and/or to create anincision in the tissue. In this embodiment, an attachment portion 116 ona proximal end of the shaft 114 can be configured to allow for removableattachment of the shaft 114 and the end effector 150 to the handleassembly 112. In particular, mating features 125 of the attachmentportion 116 can mate to complementary mating features 123 of the handleassembly 112. The mating features 123, 125 can be configured to coupletogether via, e.g., a snap fit coupling, a bayonet type coupling, etc.,although any number of complementary mating features and any type ofcoupling can be used to removably couple the shaft 114 to the handleassembly 112. Although the entire shaft 114 of the illustratedembodiment is configured to be detachable from the handle assembly 112,in some embodiments the attachment portion 116 can be configured toallow for detachment of only a distal portion of the shaft 114.Detachable coupling of the shaft 114 and/or the end effector 150 canallow for selective attachment of a desired end effector 150 for aparticular procedure, and/or for reuse of the handle assembly 112 formultiple different procedures.

The handle assembly 112 can have one or more features thereon tomanipulate and operate the end effector 150. By way of non-limitingexample, a rotation knob 126 mounted on a distal end of the handleassembly 112 can facilitate rotation of the shaft 114 and/or the endeffector 150 with respect to the handle assembly 112. The handleassembly 112 can further include clamping components as part of aclamping system actuated by trigger 122 and firing components as part ofa firing system that can also be actuated by the trigger 122. Thus, insome embodiments, movement of the trigger 122 toward a stationary handle120 through a first range of motion can actuate clamping components tocause opposed jaws 152, 154 to approximate toward one another to aclosed position. Further movement of the trigger 122 toward thestationary handle 120 through a second range of motion can actuatefiring components to cause the ejection of staples from the staplecartridge 160 and/or the advancement of a knife to sever tissue capturedbetween the jaws 152, 154.

Yet another embodiment of a surgical instrument 200 is illustrated inFIG. 7 Like surgical instruments 10 and 100, surgical instrument 200includes a handle assembly 212 with a shaft 214 extending distallytherefrom and having an end effector 250 on a distal end thereof fortreating tissue. The end effector 250 can include a cartridge assembly252 and an anvil 254, each having a tissue-contacting surface 260 p, 260d that is substantially circular in shape. The cartridge assembly 252and anvil 254 can be coupled together via a shaft 262 extending from theanvil 254 to the handle assembly 212 of the stapler 200, andmanipulating an actuator 222 on the handle assembly 220 can retract andadvance the shaft 262 to move the anvil 254 relative to the cartridgeassembly 252. In one embodiment, the shaft 262 can be formed of firstand second portions (not shown) configured to releasably couple togetherto allow the anvil 254 to be detached from the cartridge assembly 252,allowing greater flexibility in positioning the anvil 254 and thecartridge assembly 252 in a body. For example, the first portion of theshaft can be disposed within the cartridge assembly 252 and extenddistally outside of the cartridge assembly 252, terminating in a distalmating feature. The second portion of the shaft 214 can be disposedwithin the anvil 254 and extend proximally outside of the cartridgeassembly 252, terminating in a proximal mating feature. In use, theproximal and distal mating features can be coupled together to allow theanvil 254 and cartridge assembly 252 to move relative to one another.The anvil 254 and cartridge assembly 252 can perform various functionsand can be configured to capture tissue therebetween, staple the tissueby firing of staples from a cartridge assembly 252 and/or can create anincision in the tissue. In general, the cartridge assembly 252 can housea cartridge containing the staples and can deploy staples against theanvil 254 to form a circular pattern of staples around a circumferenceof a tubular body organ.

The handle assembly 212 of the stapler 200 can have various actuatorsdisposed thereon that can control movement of the stapler. For example,the handle assembly 212 can have a rotation knob 226 disposed thereon tofacilitate positioning of the end effector 250 via rotation, and/or atrigger 222 for actuation of the end effector 250. Movement of thetrigger 222 through a first range of motion can actuate components of aclamping system to approximate the jaws, i.e. move the anvil 254 towardthe cartridge assembly 252. Movement of the trigger 222 through a secondrange of motion can actuate components of a firing system to cause thestaples to deploy from the staple cartridge assembly 252 and/or causeadvancement of a knife to sever tissue captured between the cartridgeassembly 252 and the anvil 254.

The illustrated embodiments of surgical stapling instruments 10, 100,and 200 provide only a few examples of many different configurations,and associated methods of use, that can be used in conjunction with thedisclosures provided herein. Although the illustrated embodiments areall configured for use in minimally invasive procedures, it will beappreciated that instruments configured for use in open surgicalprocedures, e.g., open linear staplers as described in U.S. Pat. No.8,317,070, can be used in conjunction with the disclosures providedherein. Greater detail on the illustrated embodiments, as well asadditional exemplary embodiments of surgical staplers, componentsthereof, and their related methods of use, that can be used inaccordance with the present disclosure include those devices,components, and methods provided for in U.S. Publication No.2013/0256377, U.S. Pat. Nos. 8,393,514, 8,317,070, 7,143,925, U.S.patent application Ser. No. 14/074,884, entitled “Sealing Materials forUse in Surgical Procedures, and filed on Nov. 8, 2013, U.S. patentapplication Ser. No. 14/074,810, entitled “Hybrid Adjunct Materials forUse in Surgical Stapling,” and filed on Nov. 8, 2013, U.S. patentapplication Ser. No. 14/075,438, entitled “Positively ChargedImplantable Materials and Method of Forming the Same,” and filed on Nov.8, 2013, U.S. patent application Ser. No. 14/075,459, entitled “TissueIngrowth Materials and Method of Using the Same,” and filed on Nov. 8,2013, U.S. patent application Ser. No. 14/074,902, entitled “HybridAdjunct Materials for Use in Surgical Stapling,” and filed on Nov. 8,2013, U.S. patent application Ser. No. 14/226,142, entitled “SurgicalInstrument Comprising a Sensor System,” and filed on Mar. 26, 2014, eachof which is incorporated by reference herein in its entirety.

End Effector Variations

End effectors of the surgical stapling instruments described herein canhave one or more features for adjusting an amount of compression appliedto tissue captured by the end effector. In some embodiments, the endeffector can be configured to create a desired compression profile intissue captured therein, for example a profile that helps to minimizebleeding, tearing, and/or leakage of the treated tissue. By way ofnon-limiting example, the desired tissue compression profile can beobtained using variations in a gap between upper and lower jaws of theend effector and/or variations in the orientation, size, and/or shape ofstaples applied to tissue by the end effector. As described in detailherein, adjunct material(s) used in conjunction with such an endeffector can be configured to assist in creating the desired tissuecompression profile and/or to accommodate features used to create thedesired tissue compression profile.

Any such variations described herein can be used alone or together toprovide the desired tissue compression profile. Although exemplary endeffectors and components thereof are described in conjunction with aparticular surgical instrument, e.g., instruments 10, 100, and 200, itwill be appreciated that the end effectors and components thereof can beconfigured for use with other embodiments of surgical instruments asdescribed herein.

In some embodiments, a staple cartridge disposed within an end effectorof a surgical stapling instrument can have a first portion configured tocompress tissue captured by the end effector more than a second portionwhen the end effector is in a closed position. The first portion of thecartridge can be spaced longitudinally and/or laterally from the secondportion to create a desired compression gradient. For example, as shownin FIGS. 4 and 8, the staple cartridge 60 can have a stepped tissuecontacting surface. In particular, the cartridge 60 can have an innertissue contacting surface 62 and outer tissue contacting surfaces 64that extend upwardly to a taller height than the inner tissue contactingsurface 62. In this way, when the upper jaw 54 is in the closed positionin close approximation with the cartridge 60, the anvil surface 58 canbe configured to compress the outer surfaces 64 more than the innersurface 62 due to the taller height of the outer surfaces 64. In somecircumstances, including circumstances where tissue positioned betweenthe anvil surface 58 and the cartridge 60 has a constant, or at leastsubstantially constant, thickness, the pressure generated within thetissue can be greater at outer portions of the end effector 50 than atinner portions of the end effector 50. Whereas a compression gradientgenerated by the cartridge 60 varies in a stepped manner, it will beappreciated by a person skilled in the art that a gradual compressiongradient can be generated within the tissue by a gradual increase inheight of various portions of the cartridge 60. It will also beappreciated that a compression gradient can be obtained by variations inheight of the anvil surface 58, alone or in combination with heightvariations of the cartridge 60, and that height variations can be spacedlaterally and/or longitudinally across the end effector 50.

In some embodiments, one or more adjunct materials fixed to an endeffector of a surgical stapling instrument can be used to create adesired compression profile in tissue captured by the end effector.Referring now to FIG. 9, a compressible, implantable staple cartridge360 can be formed from one or more adjunct materials as described hereinand can be configured to be seated within an end effector of a surgicalinstrument, e.g., an end effector 350. The cartridge 360 can have aheight that decreases from a tallest height H1 at a distal end 360 dthereof to a smallest height H2 at a proximal end 360 p thereof. In thisway, when an upper jaw 354 of the end effector 350 is in the closedposition in close approximation with the cartridge 360, an upper jaw 354of the end effector 350 can be configured to compress the distal end 360d more than the proximal end 360 p. Although the compression gradientcreated in the captured tissue by the cartridge 360 decreases linearlyfrom the distal end 360 d to the proximal end 360 p, it will appreciatedby a person skilled in the art that any compression gradient can becreated by different shapes of the cartridge 360. In at least oneembodiment, a thickness of the cartridge 360 can vary across its width,similar to the cartridge 360.

In some embodiments, staples contained within a staple cartridge of anend effector can be configured to create a desired compression profilewithin tissue captured by the staples. The desired compression profilecan be created in stapled tissue, for example, where staples within thestaple cartridge have different unformed staple heights. As shown inFIG. 10, an unformed height H of the exemplary staple 70 can be measuredfrom a base 74 of the staple 70 to a top, or tip, of legs 72 a, 72 b ofthe staple 70. Referring now to FIG. 11, which illustrates a crosssection of the end effector 350, a first group of staples 370 a can havefirst staple height H1 that is taller than a second staple height H2 ofa second group of staples 370 b. The first group of the staples 370 acan be positioned in a first portion of the staple cartridge 360, forexample in an outer portion, and the second group of staples 370 b canbe positioned in a second portion of the staple cartridge 360, forexample in an inner portion. In the illustrated embodiment, thecartridge 360, and therefore the compression gradient, can be configuredto be symmetrical about a slot 367 configured to receive a cuttinginstrument, e.g., the E-beam 86, therethrough. It will be appreciated bya person skilled in the art that the first and second groups of staples370 a, 370 b can be arranged in any pattern and can be spaced laterallyand/or longitudinally along the cartridge 360. In certain embodiments, aplurality of staple groups, each group having different unformed stapleheights, can be utilized. In at least one such embodiment, a third grouphaving an intermediate staple height can be positioned in the cartridgeintermediate the first group of staples and the second group of staples.In various embodiments, each staple within a staple row in the staplecartridge can comprise a different staple height. In at least oneembodiment, the tallest staple within a staple row can be positioned ona first end of a staple row and the shortest staple can be positioned onan opposite end of the staple row. In at least one such embodiment, thestaples positioned intermediate the tallest staple and the shorteststaple can be arranged such that the staple heights descend between thetallest staple and the shortest staple, for example.

Similarly, staples within a staple cartridge can have different crownwidths to create a desired compression profile in the stapled tissue. Asshown in FIG. 10, a crown width W of the exemplary staple 70 can bemeasured from one side of the base 74 of the staple 70 to an oppositeside. Like the above-described variations in staple height H, variationsin the staple width W can be spaced throughout the staple cartridge tocreate a plurality of staple groups dispersed longitudinally and/orlaterally across the cartridge. By way of non-limiting example, FIG. 12illustrates a staple cartridge 260 for use with the surgical instrument200 and having staples 270 therein with different crown widths W. Thestaple cartridge 260 houses three groups of staples 270 a, 270 b, 270 c,each having different widths W1, W2, and W3, respectively, although anynumber of staple groups is possible. As shown, the groups of staples 270a, 270 b, 270 c can be arranged in circumferential rows, with thestaples 270 c having the largest width W1 positioned on an outermostedge of the cartridge 260 and the staples 270 a having the smallestwidth W3 positioned on an innermost edge of the cartridge 260. In otherembodiments, staples having a larger crown width can be positioned nearan inner most edge of a cartridge and staples having a smaller crownwidth can be positioned near an outer edge of the cartridge. In stillfurther embodiments, staples along the same row can have different crownwidths.

Additionally or alternatively, it may be possible to create a desiredtissue compression profile by the creation of different formed (final)staple heights. FIG. 13 illustrates an exemplary embodiment of lines offormed staples 470′ installed using a surgical stapling instrument asdescribed herein and configured to apply staples 470′ having differentformed heights as well as to cut tissue to thereby create a cut line494. As shown in FIG. 13, formed heights F1 of a first group of staples470 a′ in a first row that is the farthest distance away from the cutline 494 are greater than formed heights F3 of a third group of staples470 c′ in a third row that is closest to the cut line 494. A secondgroup of staples 470 b′ in a second row that is formed between the firstand third rows can have staples 470 b′ with a formed height F2 that isbetween the heights F1, F3. In other embodiments, formed heights of thestaples can decrease from an innermost row to an outermost row. In stillfurther embodiments, formed heights of the staples in a single row canincrease or decrease from staple to staple.

Referring again to FIG. 11, differences in formed staple heights can beattained by, for example, altering a staple forming distance A. Formingdistances A1, A2 can be measured from a seat of staples 370 a, 370 b,respectively, within the cartridge 360, and an apex of a correspondingforming pocket 366 of the anvil surface 358 when the upper jaw 354 is inthe closed position. In one embodiment, for example, a first stapleforming distance A1 is different from a second staple forming distanceA2. Because the forming distance A1 is greater than the forming distanceA2, the staples 370 a are not compressed as much as the staples 370 b,which can alter the formed heights of the staples 370 a, 370 b. Inparticular, greater amounts of compression, corresponding to smallerforming distances, can result in staples with smaller formed (final)heights. It will be understood that similar results may be attained inany desired pattern.

Varied tissue compression gradients can be obtained via patterns instaple orientation within a staple cartridge, for example by thepatterns illustrated in FIGS. 14 and 15A. In the embodiment depicted inFIG. 14, staple cartridge 560 can include at least one first staplecavity 568 a and at least one second staple cavity 568 b for housingstaples 570 therein. The first cavity 568 a can be situated on firstlateral side 563 of the cartridge 560 and the second cavity 568 b can besituated on a second lateral side 565 of the cartridge 560, the firstand second lateral sides 563, 565 being separated by a slot 567configured to receive a cutting instrument, e.g., the E-beam 86,therethrough. The first cavity 568 a can define a first longitudinalaxis 569 a and the second cavity 568 b can define a second longitudinalaxis 569 b. In the illustrated embodiment, the first axis 569 a isperpendicular, or substantially perpendicular, to the second axis 569 b.In other embodiments, the first axis 569 a can be transverse to thesecond axis 569 b such that axes 569 a, 569 b can create an acute orobtuse angle therebetween. In still other embodiments, the first axis569 a can be parallel to, or substantially parallel to, the second axis569 b. In some embodiments, at least a portion of the staple cavities568 a, 568 b can overlap, such that staples 570 therein can beinterlocked when formed. The cartridge 560 can have a plurality of eachof the first and second cavities 568 a, 568 b, which can be arranged inany pattern on first and second sides 563, 565 of the cartridge 560, forexample in rows extending along both sides 563, 565 of the cartridge 560along a longitudinal axis Lc of the cartridge 560. The staples 570housed within the cavities 568 a, 568 b can be implanted into tissue ina pattern determined by the orientation and positioning of the cavities568 a, 568 b. The cartridge 560, for example, can be used to implantstaples 570 having different orientations of the staples 570 on oppositesides of an incision line created by a surgical instrument carrying thecartridge 560.

In other embodiments, for example the embodiment of a cartridge 660illustrated in FIG. 15A, staple cavities 668 a and 668 b havingdifferent orientations can both be disposed on a single lateral side ofthe cartridge 660. As shown in FIG. 15A, an axis 669 a of the firststaple cavity 668 a is perpendicular, or substantially perpendicular, toan axis 669 b of the second staple cavity 668 b, both of which aredisposed on each of first and second lateral sides 663, 665 of thecartridge 660. In other embodiments, the axes 669 a, 669 b can form anacute or obtuse angle therebetween, or can be parallel to one another. Aplurality of the first and second cavities 668 a, 668 b can be alignedin adjacent rows along a longitudinal axis Lc′ of the cartridge 660 oneach of the first and second sides 663, 665 of the cartridge 660. Inthis embodiment, staples 670 housed within the cavities 668 a, 668 b canbe implanted into tissue in a symmetrical pattern about an incision linecreated by a surgical instrument carrying the cartridge 660. Greaterdetail on staple patterns, as well as additional embodiments of suchpatterns, can be found in U.S. Publication No. 2011/0192882,incorporated herein by reference in its entirety.

Exemplary Compositions for Adjunct Materials

Regardless of the configuration of the surgical instrument, the presentdisclosure provides for the use of implantable materials, e.g.,synthetic and/or biological materials, collectively “adjunct materials,”in conjunction with instrument operations. As shown in FIG. 15B, the endeffector 50 can include at least one piece of adjunct material 30positioned intermediate the lower and upper jaw members 52, 54 and itcan be releasably retained to one of the staple channel 56 and/or theanvil surface 58. In use, the adjunct material 30 and patient tissue canbe captured by staples 70 when the staples 70 are fired. Then, theadjunct material 30 can be separated from the surgical stapler and canremain in the patient when the stapler is removed from the patient.Exemplary devices and methods for attaching one or more adjunctmaterials to an end effector of a surgical instrument can be found inU.S. Publication No. 2013/0256377 and U.S. Publication No. 2013/0153641,incorporated herein by reference in their entirety.

Regardless of the configuration of the surgical instrument, theembodiments described herein can provide for the use of implantablematerials, e.g., synthetic and/or biological materials, collectively“adjunct materials,” in conjunction with instrument operations. Asexplained in more detail below, adjunct materials as disclosed hereincan be releasably coupled to the lower and upper haw members 52, 54 in avariety of manners to allow the adjunct materials to separate from thejaw members upon actuation of the end effector 50. More particularly,the adjunct materials can be captured by staples 70 along with tissuedisposed between the jaw members 52, 54. The adjunct materials canremain in the patient when the stapler removed from the patient. While anumber of devices and methods for attaching adjunct materials to an endeffector of a surgical instrument are described below, others can befound in U.S. Pat. Pub. No. 2013/0256377 and U.S. Pat. Pub. No.2013/0153641, incorporated herein by reference in their entirety.

In at least one embodiment, a surface on the adjunct material 30 can beconfigured to contact tissue as the tissue is clamped between the lowerand upper jaw members 52, 54. In such an embodiment, the adjunctmaterial can be used to distribute the compressive clamping force overthe tissue, absorb, reinforce, and/or retain beneficial fluids at thetreatment site, improve the purchase of the staples, and/or promoteimproved clinical outcomes such as hemostasis, pneumostasis, healing,etc. In various embodiments, one or more pieces of adjunct material canbe positioned within the end effector 50. In some embodiments, one pieceof adjunct material 30 can be attached to the staple cartridge 60 and asecond piece of adjunct material 30′ can be attached to the anvilsurface 58; however, any suitable number of adjunct materials can besituated within the end effector 50.

Adjunct material used in conjunction with the disclosures provided forherein can have any number of configurations and properties. Generally,they can be made from a bioabsorbable material, a biofragmentablematerial, and/or a material otherwise capable of being broken down, forexample, such that the adjunct material can be absorbed, dissolved,fragmented, and/or broken down during the healing process. In at leastone embodiment, the adjunct material can be configured to degrade overtime to form a gel, e.g., a sealant, to assist in wound healing. Inother embodiments, the adjunct material can include a therapeutic drugthat can be configured to be released over time to aid the tissue inhealing, for example. In further various embodiments, the adjunctmaterials can include a non-absorbable and/or a material not capable ofbeing broken down, for example.

Some particularly advantageous adjunct materials can include porouspolymer scaffolds that can be configured to be broken down, for exampleby exposure to water such that the water attacks the linkage of apolymer of the material. The degraded material can be configured to gelover a wound site to thereby coat the wounded tissue, e.g., wounded softtissue, which can aid in compressing, sealing and/or generally creatingan environment at the wound site that promotes healing of the tissue. Inparticular, such degradable polymers can allow for the tissue itself tobecome the weight-bearing component. In some embodiments, the degradedmaterial can include chemoattractant agents that attract natural healingcompounds to the wound site. The polymer scaffolds can be configured tohave a desired rate of degradation, for example within minutes to hoursafter attachment to tissue, to thereby assist in the healing processalmost immediately after attachment. For more details on porous polymerscaffolds as described herein, see Q. Chen et al., Elastomericbiomaterials for tissue engineering, Progress in Polymer Science 38(2013) 584-671, incorporated herein by reference in its entirety.

In some embodiments, the porous polymer scaffolds described herein canbe physically crosslinked, which can allow for shaping of the polymerinto various complicated three-dimensional shapes, e.g., fibers, sheets,films etc., having any desired porosity, surface-to-volume ratio, andmechanical properties. The scaffold can be shaped into a desired formvia a number of methods, for example by extrusion, wet spinning,electrospinning, thermally induced phase separation (TIPS), saltleaching/freeze-drying, etc. Where the scaffold is formed into a film orsheet, the film or sheet can have any desired thickness, for example ina range of about 50 to 750 μm or in a range of about 1 to 3 mm,depending on the desired application.

One embodiment of a porous polymer scaffold includes multiple layers,each of which can perform different wound healing functions. In anexemplary embodiment, the scaffold includes three layers. The firstlayer can be made from polyester carbonate urethane urea (PECUU), thesecond layer can be made from poly(ester urethane) urea (PEUU), and thethird layer can be made from poly(carbonate urethane) urea (PCUU) lysinetriisocyanate (LTI) or hexamethylene diisocyanate (HDI). A personskilled in the art will appreciate that the properties of each layer canbe optimized to achieve desired results and performance. In someembodiments, the desired properties of the scaffold can be achieved byblending or copolymerizing the material of the third layer orcopolymerized with various polymers or copolymers. By way ofnon-limiting examples, the material of the third layer can be blendedwith a polyester copolymer, for example polycaprolactone (PCL),polyglycolic acid PGA, poly(D,L-lactic acid) (PDLLA), PGA, and/orpolyethylene glycol (PEG). Where the material of the third layer isblended with both the polyester copolymer and the PEG, a ratio of thepolyester to the PEG in the third layer can be about 50:50. In anotherexemplary embodiment, the PCL can be present in a range of about 60-70%weight/volume, the PGA can be present in a range of about 20-30%weight/volume, the PEG can be present in a range of about 50%weight/volume, and the PDLLA can be present in a range of about 10%weight/volume.

The three-layered film can be configured to degrade almost immediatelyupon attachment to tissue, for example within about 1 to 2 hours afterattachment, although each of the three layers can be configured todegrade differently to have different healing benefits. The order,number, and thickness of each of the layers can vary, and can betailored to create desired degradation and/or compression ratios. Insome embodiments, the first, second, and third layers can be formed ontop of a base material or substrate, for example on top of PCL, whichcan be configured to aid in mechanical compression of the woundedtissue.

Another exemplary embodiment of a porous polymer scaffold can besynthesized from polyhydroxyalkanoate (PHA). In an exemplary embodiment,the PHA can be naturally produced from a variety of microorganisms,e.g., Gram-negative or Gram-positive bacteria, or it can be synthesized,e.g., similar to the production of Biopol®, available from Zeneca ofLondon, United Kingdom. Because PHAs are very quick to dissolve,scaffolds made from PHA can begin to degrade within 20 to 30 minutesafter attachment to tissue via contact with heat and/or water. Where thePHA scaffold has a higher molecular weight, the degradation time can behigher, for example in a range of about 30 minutes to about 10 hours.The PHA can be formed into a very thin film, for example a film having athickness of less than 0.1 mm, e.g., in a range of between 50 to 750 μm.In some embodiments, the PHA can be copolymerized and/or blended withone or more additional materials. By way of non-limiting example, thePHA can be copolymerized with hydroxlvalerate (HV), hydroxylbutyrate(HB), and/or hydroxylhexanoate (HH), which can reduce a level orcrystallinity and/or brittleness of the PHA. In other embodiments, thePHA can be blended with one or more thermoplastics, e.g., poly(lacticacid) (PLA), PGA, PCL, starch, etc., to thereby customize a molecularweight and resultant mechanical properties of the scaffold. In certainaspects, one or more of the polymers can be a thermoplastic polymer.

In other embodiments, the scaffold can be synthesized from poly(polyolsebacate) (PPS), e.g., from poly(glycerol-sebacate) (PGS). Suchscaffolds can be particularly biocompatible and can provide anadditional advantage of reducing a risk of infection in addition topromoting healing. Other exemplary embodiments can be synthesized fromxylitol-based elastomers, for example polyxylitol sebacates (PXSs),which can offer structural stability over a clinically required periodand/or can enter the metabolic pathway slowly without causing rapidfluctuations of blood glucose levels. Scaffolds made from PXS's can beformed into a thicker film to thereby provide greater compression to thewound site, and can be configured to degrade within a range of about 10hours to 8 days after attachment. Still other exemplary embodiments canbe synthesized from poly(glycerol sebacate-co-acrylate) (PGSA), whichcan promote tissue ingrowth into the scaffold, particularly when formedas a fiber, and/or can serve as an antibacterial agent. PGSA scaffoldscan be useful as a replacement for traditional surgical sutures andstaples, and/or can serve as a waterproof sealant for hollow organanastomoses (e.g., ducts, intestine, etc.), 2D mesh grafts (e.g.,treatment of hernias, ulcers, burns, etc.), and/or wound dressings(e.g., hemostatic patches, etc.). The PGSA can be combined withglycerol, which can allow the scaffold to last longer in situ, forexample up to 20 days.

In yet another embodiment, the scaffold can be made frompoly(e-caprolactone) (PCL), which can be blended with silk fibroin (SF)and which can be formed into a very thin film. The PCL/SF blend can havehighly biocompatible properties and/or can improve cell attachmentand/or proliferation to the scaffold. For example, when implanted ontotissue, the scaffold can release fibroin into the tissue to therebypromote faster healing, nearly immediate hemostasis, and/or to attractfibroblasts in greater numbers. The PCL component can further assist inthe healing process by providing mechanical compression of the woundedtissue. A higher PCL content can provide better mechanical properties,while a higher SF content can provide better degradation properties. Ingeneral, the PCL content can be in a range of about 50 to 90%weight/volume and the SF content can be in a range of about 10 to 50%weight/volume. More details on the properties and manufacturing methodsfor scaffolds made from PCL and SF can be found in Jun Sik Lim et al.,Fabrication and Evaluation of Poly(epsilon-caprolactone)/Silk FibroinBlend Nanofibrous Scaffold, Biopolymers 97: 265-275 (2012), incorporatedherein by reference in its entirety.

In still further embodiments, the scaffold can include PCL coated with agelatin. The scaffold can be arranged in one or more layers, for examplewith the PCL serving as a substrate. The PCL can function to increase amechanical strength of the scaffold and/or can support fibroblastadhesion and cell proliferation. More details on the properties andmanufacturing methods for scaffolds made from gelatin-coated PCL can befound in Pengcheng Zhao et al., Biodegradable fibrous scaffolds composedof gelatin coated poly(e-caprolactone) prepared by coaxialelectrospinning, J. Biomed Mater Res 83A: 372-382 (2007), incorporatedherein by reference in its entirety.

Table 1 below outlines exemplary molecular weight ranges, approximateabsorption times, and average dimensions of films made from theaforementioned porous polymer scaffold materials. It will be appreciatedby a person skilled in the art that the ranges provided in Table 1 arenot intended to be limiting, and that a molecular weight of any of thepolymers described herein can be altered to obtain the desireddegradation properties.

TABLE 1 Average molecular Approximate weight in absorption AverageAverage Average Film Daltons times thickness length width Polyestercarbonate 5,000 to 14 to 10 μm to 25.4 to 10.3 to urethane urea 80,00060 days 1 mil 100 mm 12.7 mm (PECUU) Poly(ester 5,000 to 14 to 10 μm to25.4 to 10.3 to urethane)urea 80,000 60 days 1 mil 100 mm 12.7 mm (PEUU)Poly(carbonate 10,000 to 14 to 100 μm to 25.4 to 10.3 to urethane)urea200,000 60 days 1 mil 100 mm 12.7 mm (PCUU) (preferably 15,000 to50,000) Polyhydroxyalkanoate 2.107 × 1029 to 7 to 100 μm to 25.4 to 10.3to (PHA) 2.589 × 1029 60 days 1 mil 100 mm 12.7 mm Poly(polyol sebacate)89,000 and 7 to 100 μm to 25.4 to 10.3 to (PPS) 124,000 60 days 1 mil100 mm 12.7 mm Polyxylitol sebacates 1.47 × 1027 to 7 to 100 μm to 25.4to 10.3 to (PXS's) 3.73 × 1027 60 days 1 mil 100 mm 12.7 mmPoly(glycerol 5.8 × 1026 to 7 to 100 μm to 25.4 to 10.3 tosebacate-co-acrylate) 7.5 × 1026 60 days 1 mil 100 mm 12.7 mm (PGSA)Poly(ε-caprolactone); 25,000 to 21 to 10 μm to 25.4 to 10.3 to silkfibroin; scaffold 325,000 60 days 1 mil 100 mm 12.7 mm (PCL/SF) Blend(SF) (SF) PCL/SF (50/50) 4.21 × 1028 to 2 to 4.81 × 1028 3 years (PCL)(PCL) Gelatin coated PCL 3.01 × 1028 to 7 days 100 μm to 25.4 to 10.3 to(poly (ε-caprolactone) 1.98 × 1029 (gelatin) 1 mil 100 mm 12.7 mm(gelatin) 2 to 4.21 × 1028 to 3 years 4.81 × 1028 (PCL) (PCL)

Other suitable adjunct materials can include absorbable polyurethanes,e.g., polyurethanes derived from aromatic absorbable isocyanates thatcan be similar to methylene bis(phenyl isocyanate) (MDI) and chainextender diols. The absorbable polyurethanes can be configured tohydrolytically degrade into safe and biocompatible products uponhydrolysis. Non-limiting examples of hydrolysable aromatic isocyanatesthat can be used to form the absorbable polyurethanes includeglycolate-diisocyante, caprolactone-diisocyanate, glycolate-ethyleneglycol-glycolate, glycolate-diethylene glycol-glycolate,lactate-diethylene glycol-lactate, trimester of gycolic acid withtrimethylpropane, and tetraester of glycolic acid with pentaerythritol.

Another particularly advantageous adjunct material that can be used inconjunction with the disclosures provided herein are the materials thatform the multilayered dressings disclosed in U.S. Publication No.2006/0257458, incorporated herein in its entirety, which areparticularly suited to absorb and retain fluids when compressed, e.g.,by the application of staples. Other exemplary, non-limiting examples ofsynthetic materials that can be used in conjunction with the disclosuresprovided for herein, e.g., as a buttress, include biodegradablesynthetic absorbable polymer such as a polydioxanon film sold under thetrademark PDS® or with a Polyglycerol sebacate (PGS) film or otherbiodegradable films formed from PGA (Polyglycolic acid and various formsthereof, marketed under the trademarks Vicryl, Dexon, and/or Neoveil),PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under thetrademark Monocryl), PANACRYL (Ethicon, Inc., Somerville, N.J.),Polyglactin 910, Poly glyconate, PGA/TMC (polyglycolide-trimethylenecarbonate sold under the trademark Biosyn), polyhydroxybutyrate (PHB),poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), polydioxanone(PDO) and various forms thereof (e.g., marketed under the trademark PDS)or a blend or copolymerization of any of the above. Blends and/orcopolymerizations of any of the aforementioned materials can be tailoredto have a desired molecular weight and/or degradation rate.

Some non-limiting examples of biologic derived materials that can beused in conjunction with the disclosures provided for herein, e.g., as asealant material, include platelet poor plasma (PPP), platelet richplasma (PRP), starch, chitosan, alginate, fibrin, thrombin,polysaccharide, cellulose, collagen, bovine collagen, bovinepericardium, gelatin-resorcin-formalin adhesive, oxidized regeneratedcellulose, regenerated cellulose, mussel-based adhesive, poly (aminoacid), agarose, polyetheretherketones, amylose, hyaluronan, hyaluronicacid, whey protein, cellulose gum, starch, gelatin, silk, Progel®,available from Davol Inc. of Warwick, R.I., TachoSil®, available fromBaxter of Deerfield, Ill., or other material suitable to be mixed withbiological material and introduced to a wound or defect site, includingcombinations of materials, or any material apparent to those skilled inthe art in view of the disclosures provided for herein. Biologicmaterials can be derived from a number of sources, including from thepatient in which the biologic material is to be implanted, a person thatis not the patient in which the biologic material is to be implanted, orother animals.

Additional disclosures pertaining to synthetic or polymer materials andbiologic materials that can be used in conjunction with the disclosuresprovided herein can be found in U.S. Pat. No. 7,772,352, PCT PublicationNo. WO 2014/016819, U.S. Patent Application Publication No.2006/0257458, U.S. Patent Application Publication No. 2012/0080335, U.S.Patent Application Publication No. 2012/0083835, U.S. Patent ApplicationPublication No. 2013/0256372, U.S. Patent Application Publication No.2013/0256365, U.S. Patent Application Publication No. 2013/0256376, U.S.patent application Ser. No. 13/710,931, entitled “Electrosurgical EndEffector with Tissue Tacking Features,” and filed on Dec. 11, 2012, andU.S. patent application Ser. No. 13/763,192, entitled “MultipleThickness Implantable Layers for Surgical Stapling Devices,” and filedon Feb. 8, 2013, each of which is incorporated by reference herein inits entirety.

In use, the adjunct material can come pre-loaded onto the device and/orthe staple cartridge, while in other instances the adjunct material canbe packaged separately. In instances in which the adjunct material comespre-loaded onto the device and/or the staple cartridge, the staplingprocedure can be carried out as known to those skilled in the art. Forexample, in some instances the firing of the device can be enough todisassociate the adjunct material from the device and/or the staplecartridge, thereby requiring no further action by the clinician. Inother instances any remaining connection or retention member associatingthe adjunct material with the device and/or the staple cartridge can beremoved prior to removing the instrument from the surgical site, therebyleaving the adjunct material at the surgical site. In instances in whichthe adjunct material is packaged separately, the material can bereleasably coupled to at least one component of the end effector, e.g.,the staple cartridge, prior to firing the device. The adjunct materialmay be refrigerated, and thus removed from the refrigerator and therelated packaging, and then coupled to the device using a connection orretention member as described herein or otherwise known to those skilledin the art. The stapling procedure can then be carried out as known tothose skilled in the art, and if necessary, the adjunct material can bedisassociated with the device as described above.

Adjuncts Having Strain Relieving Features

A tissue adjunct can have various configurations, but can generally beconfigured to contact tissue as the tissue is clamped between acartridge assembly and an anvil of a surgical stapler. One advantage oftissue adjuncts is their propensity to prevent or minimize leaks, suchas fluid or gas leaks. Tissue adjuncts can perform this function by oneor more of the following mechanisms: plugging holes or tears that occurat the staple puncture sites; restricting movement of tissue aroundstaple puncture sites to prevent an increase in the size of staple holesand/or to prevent tissue tears; and minimizing strain gradients thatoccur between constrained tissues within the staple line and free tissueadjacent to the staple line.

In certain aspects, the adjunct material can be used to distribute thecompressive clamping force over the tissue, absorb and retain beneficialfluids at the treatment site, improve the purchase of the staples,and/or promote hemostasis. In some embodiments, a first piece of adjunctmaterial can be attached to a cartridge assembly and a second piece ofadjunct material can be attached to an anvil; however, any suitablenumber of adjunct materials can be situated within the end effector.

The tissue adjunct can include various features and be formed fromvarious materials for assisting with sealing of tissue at a staple lineand/or for preventing the formation of leaks in the tissue. For example,a tissue adjunct can have a central region configured to be deployedonto tissue and attached thereto via staples. The tissue adjunct canfurther include an outer region, also referred to herein as a wingregion or wing portion, which can be positioned outside of a staple linewhen the adjunct is stapled to tissue. The wing portion can help to moreevenly distribute strain and/or minimize strain gradients across atissue as the tissue deforms or otherwise expands and contracts duringnormal bodily functions. In some embodiments, a sealant can be used inconjunction with the adjunct to help seal the stapled tissue. Thesealant can be introduced into a patient in a first, liquid state andcan be configured to transition to a second, hardened or solid stateafter a predetermined amount of time. When the sealant is in the first,liquid state, the sealant can seep into the adjunct and/or the stapleline and then harden therein, thereby facilitating complete sealing ofthe tissue. The adjunct and the sealant can thus cooperate to provide abetter, more complete seal of the staple line than if only the tissueadjunct or the sealant were used.

Exemplary adjuncts having central and wing regions are shown deployedonto tissue in FIGS. 16A and 16B. As shown in FIG. 16A, an adjunct 1000can include a central 1002 for receiving staples therethrough and a wingportion 1004 adjacent to the central region 1002. The central region1002 of the adjunct 1000 can be sized and shaped to correspond to a sizeand shape of a cartridge assembly 52 and/or an anvil (not shown). Forexample, FIG. 16A illustrates an adjunct 1000 having a central region1002 that corresponds in size and shape to a tissue-contacting surfaceof the cartridge assembly 52. That is, the central region 1002 can besubstantially equal in size to the tissue-contacting surface. Thecentral region 1002 of the adjunct 1000 shown in FIG. 16A can have asubstantially elongate rectangular shape defined by proximal and distaledges 1002 p, 1002 d and first and second lateral edges 1002 a, 1002 b.The proximal edge 1002 p of the central region 1002 can terminate in aproximal mating feature 1006 for coupling to a distal end 14 d of ashaft 14 of a stapler 10. At least two of the remaining three edges ofthe central region 1002 can include a wing portion 1004 extendingtherearound and forming a perimeter of the adjunct 1000. For example, asshown in FIG. 16A, the wing portion 1004 of the adjunct 1000 can extendaround the first and second lateral edges 1002 a, 1002 b and can extenddistally beyond the distal edge 1002 d of the central region 1002. Inone embodiment, adjunct 1000 is sized and position in such a way oncartridge assembly 52 so that in can be separated by a cutting member inthe stapler during use. In fact, a distal region of the wing portion1004 is always cut. As shown, the wing portion 1004 can have a modifiedstructure that is different from a structure of the central region 1002.In the illustrated embodiment, the central region 1002 can besubstantially solid, e.g. a film, and the wing portion 1004 can be amesh. As shown in FIG. 16B, when the adjunct 1000 is stapled to tissueT, the central region 1002 can have one or more rows/lines of staples1008 extending therethrough and the wing portion 1004 can extendlaterally away from the staples 1008. As shown, the adjunct 1000 stapledto the tissue T includes half of the adjunct shown in FIG. 16A becausethe cutting member in the stapler severs the tissue while the staples1008 are deployed thereon. The meshed wing portion 1004 can flex as thetissue expands and contracts and more evenly distribute a strain (orminimize a strain gradient) across a greater area of tissue than if theadjunct 1000 only included the central region 1002. For example, thewing portion 1004 can expand and contract in a direction transverse tothe longitudinal axis LC of the central region 1002. This can helpprevent the formation of pressure points which can create leaks in thestapled tissue after repeated expansion and contraction of the tissue.In certain aspects, the mesh can be formed from threads of the same filmmaterial as the central region 1002 extending in a criss-cross pattern.The longitudinal axis of half of the threads L1 can be disposed at anangle θ1 of about a 45 degrees relative to the longitudinal axis LC ofthe central region 1002, as shown, and a longitudinal axis L2 of theother half of the threads can be disposed at an angle θ2 of about a 45degree angle relative to the longitudinal axis LC of the central region1002, or can be positioned at other angles relative to the centralregion 1002. As will be appreciated by a person skilled in the art, thewing portion 1004 of the adjunct 1000 can be formed using various knownmanufacturing techniques, such as laser cutting or punching shapes suchas squares, circles, diamonds, out of the film to produce a mesh wingregion and the solid central region 1002. Two identical adjuncts 1000,1000′ can be stapled to tissue, as shown in FIG. 16B, and in certainaspects, these adjuncts 1000, 1000′ can be substantially the same insize, shape, and configuration.

Another embodiment of an adjunct 1010 is shown in FIG. 17 and alsoincludes a central region and wing region. In this embodiment, a wingportion 1014 has a plurality of openings 1018 formed therein which canallow the wing portion 1014 to flex with the tissue T during expansionand contraction of the tissue T. The openings 1018 can have varioussizes, shapes, and configurations, and can be circular, oval,rectangular, etc., and can be positioned at various locations across thewing portion 1014. In the illustrated embodiment, the openings 1018 areslits positioned in multiple rows, the rows being substantially parallelto the longitudinal axis LC of a central region 1012. A longitudinalaxis of the slits 1018 can be parallel to a longitudinal axis LS of thestaples 1008. A number of longitudinal rows and a number of openings1018 disposed in each row can vary. In the illustrated embodiment, a rowadjacent to the central region 1012 can have a smaller number ofopenings 1018 than a row adjacent to an outermost edge 1014 a of thewing portion 1014. For example, the row adjacent to the central region1012 can have about three openings 1018 formed therein while the rowadjacent to the outermost edge 1014 a of the wing portion 1014 can haveabout four openings 1018 formed therein. In this way, a flexibility ofthe wing portion 1014 can increase from the central region 1012 to thelateral edge and can further facilitate distribution of strain acrossthe tissue T.

FIGS. 18A and 18B illustrate another embodiment of a tissue adjuncthaving wings for distributing strain across the tissue. FIG. 18Aillustrates an adjunct 1020 having a central region 1022 and a wingregion 1024, both regions being formed from a plurality of layers. As inthe previous embodiments, the central region 1022 can have asubstantially rectangular shape. A top layer of material can define thecentral region 1022 and both regions 1022, 1024 can be formed from aplurality of layers. The central region 1022 can have a substantiallyrectangular shape, but can be shaped in other ways. As shown in FIG.18A, a top layer of material 1026 t can define the central region andcan be formed from a flexible material, such as PDS®, PGA, Neoveil®, ORCor other polymers and biologically derived material constructs orcombinations disclosed herein. Material geometry and structure (materialthickness, fiber orientation, polymer chain orientation, hole patterns,etc.) may be used to create desired isotropic or anisotropic deformationcharacteristics. A bottom layer of material 1026 b can also besubstantially flexible, and in certain aspects can have a greaterflexibility than the top layer 1026 t. The bottom layer 1026 b can havea shape that corresponds to a shape of the top layer 1026 t, and isshown having a substantially rectangular shape. The bottom layer 1026 bcan have a larger surface area than the top layer 1026 t such that thebottom layer 1026 b extends beyond lateral edges of the top layer 1026t. As shown, lateral edges of the bottom layer 1026 b can be scalloped,having a plurality of semicircular protrusions 1028 along the wingportion 1024. These semicircular protrusions can be spaced at equaldistances apart along the edges, or can be spaced in groups of two,three, four, and the groups of protrusions can be disposed at equaldistances apart along the edge. When the adjunct 1020 is stapled totissue, the top layer 1026 t of material 1026 t will be positioned awayfrom and will not directly contact the tissue, while the bottom layer1026 b will directly contact tissue. Additionally, the protrusions canbe positioned away from the staple rows and can distribute a strainacross the tissue T to prevent formation of leaks. The bottom layer 1062b may be formed from a flexible material, such as PDS®, PGA, Neoveil®,ORC or other polymers and biologically derived material constructs orcombinations disclosed herein. Material geometry and structure (materialthickness, fiber orientation, polymer chain orientation, hole patterns,etc.) may be used to create desired isotropic or anisotropic deformationcharacteristics. In an embodiment, at least one of top layer 1062 t andbottom layer 1062 b is at least partially comprised of PDS® to aid inattachment of adjacent layers. In an embodiment, both the top layer 1062t and bottom layer 1062 b are created from absorbable materials.

The adjunct material can be constructed in various ways. For example,the adjunct material can be formed from a continuous material. That is,as shown in FIG. 18B, the adjunct 1020 can include a single layer withthe central region 1022 and the wing portion 1024 having the pluralityof protrusions 1024 for distributing a strain. In other aspects, theadjunct can include more than two layers of material. For example, oneor more intermediate layers of material (not shown) can be positionedbetween the top layer and the bottom layer and can be more rigid thanthe top and bottom layers. The layers can be coupled together usingknown manufacturing techniques, such as lamination, adhesive, etc. Theprotrusions 1028 on the wing portion 1024 of the adjunct can also beformed using known manufacturing techniques, such as laser cutting,stamping, punching, etc.

Another exemplary adjunct is shown in FIG. 19 and includes a wing regionhaving a varied geometry. As shown, an adjunct 1020′ can have a wingregion 1024′ extending around a perimeter of the central region 1022′and can have a plurality of surface features 1028′ formed therein andspaced evenly along the wing region 1024′. The surface features 1028′can be generally shaped as a boomerang and can include an elbow 1023′and first and second arms 1025′, 1027′ extending therefrom. As shown inFIG. 19, the elbow 1023′ can be positioned along edges 1022 a′, 1022 b′,1022 c′ of the central region 1022′ while terminal ends 1025 t′, 1027 t′of the arms 1025′, 1027′ can be positioned at an outer edge of the wingregion 1024′. In this way, a thickness of the wing region 1024′ in adirection transverse to a longitudinal axis of the central region 1022′can vary and a thickness of the wing region 1024′ in a directionparallel to the longitudinal axis of the central region 1022′ can alsovary. These surface features 1028′ can be formed by removing a portionof the adjunct material 1020′ using known manufacturing techniques, suchas laser cutting, stamping, punching, etc.

FIGS. 20A-20C illustrate adjunct material including wing portions withmodified edges. For example, a wing portion 1034 of an adjunct 1030 ofFIG. 20A can have an outer edge in the shape of a sine wave with peaks1034 p and valleys 1034 v along its length so that the wing portion 1034is atraumatic and does not increase a likelihood of forming leaks intissue. A wing portion 1034′ of FIG. 20B includes a first material 1036′forming a central region 1032′ and the wing portion 1034′, the wingportion 1034′ having curved edges which loop around and extend towardthe central region 1032′, and back toward the edge forming an oblongopening 1035′. In certain aspects, a second material 1038′ is disposedin the oblong, teardrop shaped openings 1035′, such as by beinglaminated to the first material 1036′ to form the adjunct 1030′. Athickness of this second material 1038′ can vary from a thickness of thefirst material 1036′. For example, the thickness of the second material1038′ can be less than the thickness of the first material 1036′, asshown. A wing portion 1034″ of FIG. 20C can have a plurality of openings1035″ formed therein, such as triangular shaped openings, that can formprotrusions 1038″ similar to those protrusions 1028 shown in FIG. 18B,but the protrusions 1038″ can have corners rather than rounded edges.The adjuncts 1030, 1030′, 1030″ of FIGS. 20A-20C can be formed fromdifferent materials, such as any flexible or stretchable polymermaterial described herein. In use, any one of the adjuncts 1030, 1030′,1030″ can be stapled to tissue and any of the respective wing portionscan extend beyond the staple line. A shown in FIG. 20D, the adjunct 1030can be stapled to tissue T and the wing portion 1034 can be positionedoutside of the staples 1008 which form a staple line and the centralportion 1032 can be positioned inside of the staple line. In certainaspects, as the tissue expands and contracts, the adjuncts can stretchor flex in a direction transverse to the staple rows or can beconfigured to stretch in multiple directions, such as along an outersurface of the tissue T as shown. A person skilled in the art willappreciate that the edges of the wing portions can be shaped in otherways than the illustrated embodiments.

FIGS. 21A-21C illustrate another embodiment of adjunct materialincluding a wing portion with modified edges. As shown in FIG. 21A, anadjunct material 1040 can be woven. A central region 1042 of the adjunct1040 can be formed from a woven material of higher density than a wovenmaterial at a wing portion 1044 of the adjunct 1040. In other aspects, aless dense woven material can encase a denser woven material on allsides, as shown in FIG. 21B. In both embodiments, the wing portion 1044can have soft, atraumatic edges 1046 that have a decreased likelihood ofpuncturing or otherwise damaging the tissue and causing holes to formtherein. The adjunct 1040 can be configured to wick and/or absorb liquidtherein. For example, in the embodiment of FIG. 21C, a top layer 1048 t′of material of an adjunct 1040′ is shown positioned over a bottom layerof material 1048 b′, liquid 1047′ being wicked through the top layer ofmaterial and into a space between the top and bottom layers 1048 b′,1048 t′. These adjunct materials can be formed from various wovenmaterials known in the art, such as ETHISORB® (Ethicon, Inc.,Somerville, N.J.). In one embodiment, central region 1042 may be a filmcomprised of solid, but deformable absorbable material.

An adjunct material for use with a stapler that deploys variablethickness staples is shown in FIGS. 22A-22D. As shown, a thickness of anadjunct 1050 can vary from a central axis 1056 to an outer edge of theadjunct 1050 in a lateral direction indicated by arrows. That is, theadjunct 1050 can have a decreasing/tapering thickness from the centralaxis 1056 of the adjunct 1050 to the outer edge thereof in the lateraldirection. As in the previous embodiments, the adjunct material 1050 caninclude a central region 1052 and wing portion 1054. The adjunct 1050can include an elongate slot 1058 formed along the central axis 1056 ofthe adjunct 1050 and having a size and shape that corresponds to a sizeand shape of a cutting member (not shown). In the illustratedembodiment, the elongate slot 1058 has a substantially rectangularshape. FIGS. 22B and 22C provide end views of a cartridge assembly 52and an anvil 54 having a varying thickness in a lateral direction suchthat the stapler 10 can deploy staples (not shown) of varying heights.As shown, a thickness TO of the anvil 54 near the cutting member slotcan be greater than a thickness TE of the anvil 54 near its lateraledge. The adjunct 1050 can be coupled to the cartridge assembly 52and/or to the anvil 54 with at least the central region 1052 of theadjunct 1050 directly contacting the tissue-contacting surface 60, 58 ofthe cartridge assembly 52/anvil 54. The tissue-contacting surface 58 ofthe anvil 54 can include one or more mating points 1057 attaching theadjunct 1050 to the anvil 54, as shown. The wing portion 1054 of theadjunct 1050 can be folded around the cartridge assembly 52 and/or theanvil 54 and attached thereto, as will be described in greater detailbelow. In this way, a tissue-contacting surface 1053 of the firstadjunct 1050 can be substantially planar and can be disposed parallel toa tissue contacting surface 1053′ of the second adjunct 1050′ disposedon the cartridge assembly 52. When the adjuncts 1050, 1050′ are stapledonto tissue, as shown in FIG. 22D, the wing portion of the adjunct 1050can be disposed between the staples 1008 and extend toward a cutterminal end TE of the tissue T, while a second portion of the adjunct1050 can extend away from the cut terminal end TE of the tissue T anddistribute strain to the tissue T, similar to the wing portionsdescribed above. The adjunct 1050′ can have similarly positionedportions 1052′, 1054′, as shown.

Any of the adjunct materials can include various features for increasingfriction between the adjunct material and the tissue to ensure that theadjunct material remains in a desired position. For example, adjuncts1060, 1060′ in FIGS. 23A and 23B include a plurality of teeth 1061,1061′ formed on a tissue-contacting surface thereof and terminating inpoints 1063, 1063′ that can penetrate into tissue. As shown, theplurality of teeth 1061, 1061′ can be spaced at equal distances apart inthe lateral direction of the adjunct 1060, 1060′. The teeth 1061, 1061′can be formed in the adjunct 1060, 1060′ using various knownmanufacturing techniques, such as via compression molding, cut/stamping,punching, etc. For example, the adjunct 1060 of FIG. 23A can becompression molded while the adjunct 1060′ of FIG. 23B can be formedfrom stamping slits 1065′ into material to form the teeth 1061′. Thegaps between the teeth 1061, 1061′ can push into tissue T and create alock that prevents sliding of the adjunct 1060, 1060′, as in FIG. 23Cwhich illustrates multiple rows of adjuncts 1060′. In another embodimentshown in FIG. 24A, the adjunct 1060″ can include a plurality ofmicropillars 1063″ formed on a tissue-contacting surface thereof, themicropillars 1063″ being shaped as needles configured to penetrate intotissue T. The teeth 1063 and/or micropillars 1063″ can directlypenetrate into the tissue T as shown in FIGS. 23D and 24B and canthereby prevent the adjunct 1060, 1060″ from sliding relative to thestaples 1008 as the tissue T expands and contracts. In certain aspects,the micropillars 1063″ can have a diameter D1 in the range of about 0.01to 0.50 mm and a height H1 in the range of about 0.05 to 0.50 mm.

Another embodiment of an adjunct material is shown in FIGS. 25A-25C. Inthis embodiment, an adjunct material such as the adjunct 1000 of FIGS.16A and 16B is used in conjunction with a nose extension member 1070that can be coupled to an anvil 54 and/or a cartridge assembly 52 of asurgical stapler 10. As shown in FIG. 25A, a distal end 1004 d of theadjunct 1000, that is, the distal end 1004 d of the wing portion 1004can terminate at or proximal to a distal-most end 52 d of the cartridgeassembly 52. As shown in FIG. 25B, a distal end 1004 d of the adjunct1000, that is, the distal end 1004 d of the wing portion 1004 canterminate at or proximal to a distal-most end 54 d of the anvil 54. Thenose extension member 1070 can be added onto the cartridge assembly 52and/or the anvil 54 to replace or supplement a distal portion of theadjunct material 1000. A proximal end 1070 p of the nose extensionmember 1070 can have a cutout 1072 formed therein and sized so as to notobstruct or cover a slot formed in the anvil 54 for receiving a cuttingmember (not shown). The cutout 1072 can define first and secondextension arms 1074 a, 1074 b which can be releasably coupled to thedistal end 54 d of the anvil 54 along a curved portion of the anvil 54that is distal to the anvil's 54 tissue contacting surface in variousways, such as using an adhesive. A distal-most end 1070 d of the noseextension member 1070 can be substantially rounded. A mechanism forreleasing a distal portion 1076 of the nose extension 1070 from theproximal end 1070 p of the nose extension 1070 can also be provided. Incertain aspects, this releasing mechanism can consist of a perforation1078 extending transverse to a longitudinal axis LN of the noseextension member 1070. In use, an adjunct 1000 can be positioned on theanvil 54 and the nose extension member 1070 can also be coupled to theanvil 54. The anvil 54 and cartridge assembly 52 can grasp tissue Ttherebetween, and a portion of the adjunct 1000 can extend distallybeyond the nose extension member 1070, as shown in FIG. 25B. That is,the distal end 1070 d of the nose extension member 1070 can bepositioned distal to the distal end 1004 d of the adjunct 1000. Theanvil 54 and the cartridge assembly 52 can deploy staples 1008 throughthe tissue T and through the adjunct 1000, while the wing region 1004 ofthe adjunct 1000 does not include staples 1008 extending therethrough.The wing region 1004 of the adjunct 1000 can directly contact the tissueT and the nose extension member 1070 can be positioned above the wingregion 1004. In certain aspects, the nose extension member 1070 can be asemi-flexible material and can be used in conjunction with the adjunct1000 to help relieve a strain on tissue T and/or provide strength to theadjunct 1000. In use, the distal end of the nose extension member 1070can be removed from the anvil 54 and/or the cartridge prior to, during,and/or after the tissue T is stapled.

While features of the adjunct described above were illustrated asseparate embodiments, an adjunct can have any combination of featuresdescribed above.

Mechanisms for Attaching and Releasing Adjuncts from an End Effector

Various mechanisms can be used to attach and then release an adjuncthaving wings from an end effector, e.g. a cartridge assembly 52 or ananvil 54. While the embodiments described below include features formedon an anvil 54, any of these features can be formed on a cartridgeassembly 52 for mating an adjunct to the cartridge assembly 52. FIGS.26A-26B illustrate adjunct material 1000′, 1000″ having mating featureskeyed to corresponding mating features formed on an anvil 54. Morespecifically, FIG. 26A shows an adjunct 1000′ having a plurality ofcylindrical protrusions 1003′ formed on a surface 1007′ that is orientedaway from a tissue contacting surface 1005′ of the adjunct 1000′. WhileFIG. 26A illustrates three cylindrical protrusions 1003′ spaced apartalong an axis parallel to a longitudinal axis LA of the anvil 54, anynumber of protrusions 1003′ can be formed at various locations along theadjunct 1000′. A lateral surface 54L of the anvil 54 can have aplurality of depressions 53 configured to receive the plurality ofprotrusions 1003′ from the adjunct 1000′ therein. In one embodiment, aheight (not shown) of the cylindrical protrusions 1003′ can vary, andcan be in the range of about 0.25 to 1.00 mm, the height measuredperpendicular to the surface 1007′ of the adjunct 1000′. The protrusions1003′ formed on the adjunct 1000′ can have other sizes and shapes. Asshown in FIG. 26B, in another embodiment, an adjunct 1000″ can have asingle elongate rectangular protrusion 1003″ extending parallel to thelongitudinal axis LA of the anvil 54. A lateral surface of the anvil 54can also include a corresponding elongate rectangular depression 53′ forreceiving the rectangular protrusion 1003″ therein when the adjunct1000″ is folded around the anvil 54. A height (not shown) of therectangular protrusion 1003″ can also vary, but can be in substantiallythe same range as the height of the cylindrical protrusions 1003′described above. While only a first lateral surface 54L of the anvil 54is shown in FIGS. 26A and 26B, a person skilled in the art willappreciate that identical protrusion(s) can be formed on a secondlateral surface (not shown) of the anvil 54. Similarly, identicaldepression(s) can be formed on a second lateral surface (not shown) ofthe adjuncts 1000′, 1000″.

An adjunct can be coupled to an anvil/cartridge assembly in other ways.As shown in FIGS. 27A and 27B, a strand of suture 1003′″ can couple theadjunct to the anvil 54. The suture 1003′″ can extend from the firstlateral surface 54L of the anvil 54, across the tissue-contactingsurface of the adjunct, and to the second lateral surface 55L of theanvil 54. First and second depressions 53′″, 55″ can be formed in thefirst and second lateral surfaces of the anvil 54, and a first terminalend of the suture 1003′″ can be received in the first depression 53′″and a second terminal end can be received in the second depression 55′″.A length of the suture 1003′″ and/or a size of the depressions 53′″, 55″can be selected so that the suture 1003′″ is taught when the terminalends of the suture 1003′″ are positioned within the depressions 53′″,55′″. As a cutting member 59 advances through the anvil 54 during and/orafter the staples 1008 are deployed into the tissue T, as shown in FIG.27B, the cutting member 59 can sever the suture 1003′″, causing theterminal ends of the suture 1003′″ to slide out of the depressions 53′″,55″ and thereby releasing the adjunct from the anvil. FIGS. 28A and 28Billustrate the strand of suture 1003′″ extending around an anvil 54 andcoupling a multi-layer adjunct 1020 to the anvil 54. As in the previousembodiment, advancement of the cutting member (not shown) relative tothe anvil 54 can sever the suture 1003′″ and release the suture 1003′″from the depressions 53′″, 55′″ in the anvil 54 to release the adjunct1020. As will be appreciated by a person skilled in the art, any numberof strands of suture can be used to couple the adjunct to one of thecartridge assembly 52 and the anvil 54 and the depressions formedtherein can vary so long as they are configured to receive a portion ofthe suture therein.

FIGS. 29A-29B illustrate other mechanisms for attaching an adjunct to ananvil/cartridge assembly. In this embodiment, the anvil 54 of a surgicalstapler 10 includes a cutting member 59 that can advance within the slot61, referred to as a longitudinal track, and can move between proximaland distal ends 61 p, 61 d of the track 61. A driver 1081 includingfirst and second elongate members (not shown) can be disposed in thelongitudinal track 61, as in FIG. 29B. Three cylindrical protrusions(not shown) extend from the elongate members and into depressions 53″″,55″″ formed in both lateral surfaces of the anvil 54, but there can beany number of protrusions spaced along the driver and having variousother shapes. As shown in FIG. 29C, a first driver 1081 a can begenerally elongate and can have a plurality of protrusions 1083, such asthree protrusions 1083, oriented transverse to a longitudinal axis ofthe driver, the protrusions 1083 being cylindrical shaped. A wingportion 1084 of an adjunct material 1080 can be disposed around alateral surface of the anvil 54 and can include a plurality ofprotrusions 1083′ oriented transverse to the longitudinal axis LA of theanvil 54 when the adjunct material 1080 is coupled thereto. As shown inFIG. 29D, the adjunct material 1080 can have a first set of protrusions1083′ for mating with the first lateral surface of the anvil 54 and asecond set of protrusions 1083″ for mating with the second lateralsurface of the anvil 54. Prior to use, the first driver 1081 a can bepositioned on a first lateral wall of the track 61 and the second driver1081 b can be positioned on a second lateral wall of the track 61. Aproximal end of each driver 1081 a, 1081 b can have an angled portion1085 p, 1087 p such that when the drivers 1081 a, 1081 b are disposed inthe track 61, a width W1 between the drivers 1081 a, 1081 b at aproximal end of the track 61 is greater than a width W2 between thedrivers 1081 a, 1081 b at and/or distal to the protrusions 1083′, thewidth being measured transverse to the longitudinal axis LA of the anvil54 as shown in FIG. 29E. Additionally, the width W2 between the drivers1081 a, 1081 b distal to the proximal end 61 p of the track 61 can beless than a width WC of the cutting member 59. In this way, the cuttingmember 59 can be advanced toward the distal end 54 d of the anvil 54 andcan increase a width between the drivers 1081 a, 1081 b and theprotrusions 1083 can push the corresponding protrusions 1083′ on theadjunct 1080 off of and away from the anvil as in FIG. 29F, therebyreleasing the adjunct from the anvil 54. In certain aspects, the adjunct1080 can be biased to a flattened, substantially planar configurationsuch that when the cutting member 59 advances within the track 61 andexerts a force on the drivers 1081 a, 1081 b, the adjunct 1080 is moreable to release from the anvil 54.

A loading mechanism for loading an adjunct onto an anvil/cartridgeassembly is shown in FIGS. 30A-30B. A loading mechanism 1090 can havevarious sizes, shapes, and configurations, and can include a firstcurved arm 1092 a and a second curved arm 1092 b having a radius ofcurvature that corresponds to a radius of curvature of the first andsecond lateral surfaces 54L, 55L of the anvil 54 and the arms 1092 a,1092 b can terminate in angled features 1093 a, 1093 b that can begrasped by a user. The loading mechanism 1090 can have a planar base1094 from which each of the first and second curved arms 1092 a, 1092 bextend. The base 1094 of the loading mechanism 1090 can further includea track extension 1094 e extending perpendicular to the base 1094 anddisposed along a central longitudinal axis of the loading mechanism 1090for insertion into the cutting member slot 54 s in the anvil 54, asshown in FIG. 30B. A first inner surface 1094 a of the loading mechanism1090 can be defined by the first curved arm 1092 a and a first portionof the base 1094 from the first arm 1092 a to the track extension, asshown in FIG. 30A Likewise, a second inner surface 1094 b of the loadingmechanism 1090 can be defined by the second curved arm 1092 b and asecond portion of the base 1094 from the second arm 1092 b to the trackextension 1094 e. In this way, the loading mechanism 1090 can begenerally E-shaped for receiving the anvil 54. An adjunct 1000 having acentral region 1002 and a wing region 1004 can be positioned andsandwiched between inner surfaces of the loading mechanism 1090 and thetissue-contacting surface of the anvil 54, as in FIG. 30B, the loadingmechanism 1090 clamping onto the anvil 54 as shown. The track extension1094 e can facilitate achieving a tight fit between the loadingmechanism 1090, the adjunct 1000, and the anvil 54 with substantially nogaps between. After the adjunct 1000 is coupled to the anvil 54, such asusing any attachment mechanisms described herein, such as attachmentmechanisms 1052, the loading mechanism 1090 can be removed from theanvil 54. This can be accomplished, for example, by pressing the angledfeatures 1093 a, 1093 b of the curved arms away 1092 a, 1092 b from oneanother, leaving the anvil 54 loaded with the adjunct 1000 as in FIG.30C.

Another exemplary loading mechanism is shown in FIGS. 31A-31C. A loadingmechanism 1090′ can be packaged as a kit along with an end effector of astapler. Alternatively, loading mechanism 1090′ may be packagedseparately. As in FIG. 31A, the anvil 54 and cartridge assembly 52 ofthe end effector 50 can include an adjunct material 1000 preloadedthereon or in another non-illustrated embodiment, the adjunct material1000 can be fixed to the anvil 54 and the cartridge assembly 52 afterbeing removed from packaging 1100. This loading mechanism 1090′ can beconfigured to wrap the wing portion 1004 of the adjunct 1000 around thelateral surfaces 54L, 53L of the anvil/cartridge assembly 54, 52 suchthat the wing portion is passively coupled to the anvil/cartridgeassembly 54, 52. As shown in FIG. 31B, the loading mechanism 1090′ canbe configured to contact the central region (not shown) of the adjunct1000 against the tissue-contacting surface of the anvil/cartridgeassembly 54, 52 and, if needed, can be configured to shape the wingportion (not shown) around the anvil 54. The loading mechanism 1090′ canbe formed of a single molded material having an upper retaining portion1104 and a lower retaining portion 1102, the retaining portions having achannel (not shown) sized and shaped for receiving the anvil/cartridgeassembly 54, 52 therein. A shape of the channel can be substantiallysimilar to the shape of the loading mechanism 1090 previously describedand can include any of the same features, such as the track extension.The upper and lower retaining portions 1104, 1102 can be disposed at anangle AL relative to one another, the angle being in the range of about10 to 40 degrees. A support member 1106 can extend between a lowersurface of the upper retaining portion 1104 and an upper surface of thelower retaining portion 1102 such that the angle AL between theretaining portions 1102, 1104 is fixed. The support member 1106 can be asubstantially solid member, as shown, so as to provide rigidity to theloading mechanism 1090′. A first end of the support member 1106 canterminate in a grasping feature 1108, and the grasping feature 1108 canhave first and second planar surfaces 1108 a, 1108 b configured to begrasped by a user, such as between a thumb and finger of a user. Thegrasping feature 1108 can further include one or more surface features1110 for increasing friction between a user's fingers. A longitudinalaxis of the grasping feature 1108 can be oriented perpendicular to alongitudinal axis of the stapler 10 or can be parallel to thelongitudinal axis of the stapler 10. In use, a user can grasp thegrasping feature 1108 and position distal ends 1102 d, 1104 d of theretaining portions adjacent to proximal ends 52 p, 54 p of the cartridgeassembly 52 and the anvil 54. A user can advance the distal end of theloading mechanism 1090′ toward the proximal end of the end effector 50,as shown in FIG. 31B, and the retaining portions 1102, 1104 can slidealong the anvil/cartridge assembly 54, 52 and force the adjunct material1000 around the lateral surfaces thereof, as shown in FIG. 31C. This cantemporarily secure the wing region 1004 along the lateral surfaces ofthe cartridge assembly 52 and the anvil 54. With the wing region 1004 sopositioned, a user can retract the loading mechanism 1090′ in theopposite direction, distally away from the end effector 50, leaving theend effector 50 prepared for insertion into a patient. While referenceis made to a single adjunct material 1000 loaded onto the anvil 54,adjunct material 1000′ can similar be loaded onto the cartridge assembly52. The adjunct material 1000, such as the material shown in FIGS.31A-31C, can be a shape memory material such that the adjunct 1000 isbiased to a substantially straightened configuration. That is, when theend effector 50 is positioned inside of the patient, the wing regionscan automatically move back to the substantially straightenedconfiguration prior to being deployed off of the end effector 50 andonto tissue.

Delivering Adjuncts into a Patient

End effectors having one or more adjuncts coupled thereto can bedelivered into various areas of a patient, such as a chest cavity,stomach, etc. As will be appreciated by a person skilled in the art, anadjunct can be delivered through an access port, such as a trocarextending into the patient. Any of the adjuncts herein can includefeatures that assist with delivery of the adjunct into a patient's body.For example, FIG. 32A illustrate an adjunct 1000 having a solid centralregion 1002 and mesh wing region 1004 coupled to an anvil 54 of asurgical stapler 10. While a single adjunct 1000 is shown coupled to theanvil 54, another adjunct 1000′ can be coupled to the cartridge assembly52 prior to inserting the end effector 50 into a patient's body. Adistal portion of the adjunct 1000, such as a distal portion 1004 d ofthe wing region 1004, can be configured to guide proximal portions 1004p of the wing region 1004 around the lateral surfaces (not shown) of theanvil 54 so as to minimize width of the adjunct material, as shown inFIG. 32B. This can facilitate insertion of the end effector 50 and theadjunct 1000 into an access port, such as a port 1202 formed in a trocar1200, because a width of the anvil/cartridge assembly 54, 52 includingthe adjunct 1000 thereon will be about the same as a width of theanvil/cartridge assembly 54, 52 without an adjunct. In certain aspects,this distal portion 1004 d of the wing region 1004 can be formed from amore rigid material than remaining portions of the wing region 1004 tohelp guide the adjunct material 1000 into the port 1202.

Stapling Adjuncts onto Tissue

An adjunct material can include features facilitating multiple firingsof staples along tissue. FIG. 33A illustrates an embodiment 1300 of anend effector 50 having first and second adjunct materials 1400, 1400′,the first adjunct material 1400 being coupled to the anvil 54 and thesecond adjunct material 1400′ being coupled to the cartridge assembly52. As shown, each of the adjunct materials 1400, 1400′ can includemultiple layers, and the layers can have various widths in the directiontransverse to a longitudinal axis (not shown) of the anvil/cartridgeassembly 54, 52. A first tissue-contacting layer 1402, 1402′ of eachadjunct 1400, 1400′ can be positioned adjacent to tissue (not shown)when tissue is grasped between the anvil 54 and the cartridge assembly52. In certain aspects, the first tissue-contacting layer 1402, 1402′can be formed from a material configured to seal around a staple line,such as an elastomeric material. The first tissue-contacting layer 1402,1402′ can have a width W5 in a direction transverse to the longitudinalaxis LA of the anvil 54 that is substantially equal to a width WA of theanvil 54, or the width W5 of the first layer 1402 can be less than thewidth WA of the anvil 54. As shown in FIG. 33A, the firsttissue-contacting layer 1402 can include a first portion 1402 apositioned on a first side of the cutting member slot 54 s and a secondportion 1402 b positioned on a second side of the cutting member slot 54s rather than being formed from a continuous piece of material. In otheraspects, the first layer 1402 can be a single continuous piece ofmaterial. A second layer 1406, 1406′ can be positioned closer to thetissue-contacting surface of the anvil 54 and can be formed from asubstantially rigid material. As shown, a width W6 of the second layer1406 can be greater than the width WA of the anvil 54. This second layer1406, 1406′ can help prevent stretching of the tissue T near the staples1008. A third layer 1408, 1408′ can be positioned closest to thetissue-contacting surface of the anvil 54 such that the second layer1406, 1406′ is sandwiched between the first and third layers 1402, 1402′and 1408, 1408′. The third layer 1408, 1408′ can have a width W7 that isgreater than the width WA of the anvil 54, but less than the width W6 ofthe second layer 1406, as shown. This third layer 1408, 1408′ can besemi-rigid to help relieve strain on tissue T as the tissue T expandsand contracts. A longitudinal length of the layers can also vary, thelength being measured in the direction transverse to the widths.

Preferably, the third layer 1408, 1408′ has a longest length measuredalong the longitudinal axis of the anvil 54 compared to a longitudinallength of each of the first and second layers 1402, 1402′, 1406, 1406′.As shown in FIG. 33B, multiple adjuncts 1400, 1400′, 1400″ can besequentially deployed onto tissue in a row and the longitudinal lengthsof the layers can result in regions 1410 a, 1410 b where the first layer1402 of one adjunct 1400 overlaps with a first layer 1402′ of anotheradjunct 1400′. In this way, the staples 1008 can still penetrate throughthese overlapping regions than if multiple, e.g. three or more layers1402, 1406, 1408 were positioned there. FIG. 33C illustrates twoadjuncts 1400, 1400′ stapled onto the tissue T at about a 90 degreeangle relative thereto, the first adjunct 1400 having a first terminalend and the second adjunct 1400′ having a second terminal end. The firstand second terminal ends form the overlapping region 1410 a, as shown.These adjuncts 1400, 1400′ can be used to allow a user to deployadjuncts to accommodate various geometries of tissue. These multilayeradjuncts 1400, 1400′ can vary in any number of ways. While the layers1402, 1406, 1408 can have various thicknesses, in the illustratedembodiment the second layer 1406 has a smaller thickness than athickness of each of the first and third layers 1402, 1408. For example,the first layer 1402 can be in the range of about 3 to 15 mm, the secondlayer 1406 can be in the range of about 5 to 20 mm, and the third layer1408 can be in the range of about 3 to 20 mm. In certain aspects, theselayers 1402, 1404, 1406 and 1402′, 1404′, 1406′ can be laminatedtogether prior to being coupled to the anvil/cartridge assembly 54, 52.In certain aspects, layers 1406 and 1406′ may be at least partiallycomprised of an absorbable material such as PDS®.

Reinforcing Tissue with Sealant and Adjuncts

Any of the adjuncts herein can be used in conjunction with a sealant tohelp maintain a seal around staples as the tissue expands and contractsfollowing a surgery. A sealant can have various formulations anddiffering viscosity and curing behavior. Generally, a sealant can bemade from a biocompatible and bioabsorbable material that can beconfigured to transition from a first, liquid state to a second,hardened state via a curing process, such as a polymerization reaction.The first state can be a softened state, e.g., a fluid, a gel, a foam,etc. and the second state can be a hardened state, e.g., a solid, arigid member, etc. When the sealant is in the first, softened state, thesealant can flow through the delivery tube and into the sealing cuff, asdescribed in greater detail below. The sealant can transition from thefirst, softened state to the second, hardened state after apredetermined amount of time. In certain aspects, the sealant can beformed from biologic material. In some embodiments, the sealant canassist in wound healing by releasing various chemical compounds, duringand/or after curing of the sealant in a patient's body. By way ofnon-limiting example, the sealant can be configured to release atherapeutic drug, such as promoters of wound healing (e.g., transforminggrowth factor-beta, etc.), antibacterial agents (e.g., triclosean,ionized silver, etc.), and other known agents over time to aid thetissue in healing near the location of the sealant in a body. In oneembodiment, a fibrin sealant can include two reactive componentscombined immediately prior to delivery into a patient, such as Thrombinand a biologically active component (BAC2), Fibrinogen and Factor XIIIIn certain aspects, the components can be provided in a 5:1 volumetricratio of BAC2 to Thrombin. In an alternative embodiment, the materialmay be the fibrin sealant sold under the trade name Evicel®. In anotherembodiment, the sealant can be blood, such as autologous blood.

FIG. 34A illustrates the adjunct of FIG. 16B having sealant 1500delivered thereon. As shown, the sealant 1500 can be delivered so thatit substantially covers the central 1002 and wing regions 1004 of theadjunct 1000 or in another embodiment (not shown), the sealant 1500 canbe selectively delivered onto only the central region 1002 and not ontothe wing region 1004.

The sealant 1500 can be delivered to an adjunct in other ways, and neednot be delivered to an outer surface of the adjunct 1000. For example,FIG. 34B illustrates multilayer adjuncts 1700, 1700′ stapled onto tissueT. The layers 1702, 1704 can be formed from various materials, but inthe illustrated embodiment include a first layer 1702 of fibrousscaffold positioned adjacent to the tissue T and a second layer 1704consisting of an elastic film. A delivery tool 1706 having an injectionneedle 1708 can have a sealant 1500 disposed therein and can penetrateinto the first layer 1702 of fibrous scaffold. The sealant 1500 can bedelivered to this first layer 1702, as in FIG. 34C and the injectionneedle 1708 can be removed from the patient's body. The sealant 1500 canbind directly onto the tissue T and/or may be held in firm apposition tothe tissue by layer 1704, and as in other embodiments, can have a wingregion 1704, 1704′ that distributes a strain to tissue beyond thestaples 1008 at the staple line. When the sealant is Evicel®, thematerial forms a fibrin clot from fibrinogen. Without a loss ingenerality, other sealants form a hardened sealing structure bydifferent mechanisms that are useful for sealing leak pathways. Thecombination of sealant 1500 and adjunct material 1700 can preventformation of leaks as the tissue T expands and contracts. The adjuncts1700′ and layers 1702′, 1704′ can be substantially similar to theadjunct 1700 and 1702, 1704 layers previously described.

A sealant can be used to reinforce tissue in other ways. For example,FIGS. 35A-35C illustrate sealant 1500 being delivered to a chest cavity1800 of a patient. As shown in FIG. 35A, a system 1900 for delivering asealant 1500 can include a container or canister 1902 for receivingcomponents A, B, C of a sealant 1500 therein. In certain aspects, thecomponents A, B, C can include acid solubilized collagen A, fibrinogenB, and thrombin C. A trocar 1200 can extend through an incision 1904formed in a patient 1906 and into the chest cavity 1800. An applicatortool 1908 can have a shaft 1910 extending through the trocar 1200, adistal end 1910 d of the shaft 1910 terminating in the chest cavity. Ahandle assembly can be formed on a proximal end 1910 p of the shaft 1900and can be configured to be grasped be a user. The handle assembly 1912can be a pistol-grip type handle assembly and can include one or moreactuators, such as a lever 1914 that can be pivoted to actuate thedevice 1908. The canister 1902 and the applicator tool 1908 can becoupled together in various ways, such as via a tube 1916. This tube1916 can be substantially flexible to facilitate movement of theapplicator tool 1908 during a procedure. The canister 1902 can have asecond tube 1918 coupled thereto and connected to a gas source S so thatgas 1920 can be delivered to the canister 1902. The gas 1920 caninclude, by way of non-limiting example, CO₂, O₂, etc. In certainaspects, the gas source S can be a continuous gas source such as acontinuous CO₂ gas source available in hospital operating rooms. One ormore valves (not shown) can be disposed in the tube 1916, in the handleassembly 1912, in the shaft 1910, or in any other portion of the system1900 and can be selectively opened and closed by activating theactuator, such as by pivoting the actuator 1914 on the handle assembly1912. For example, one valve can control influx of the gas 1920 into thecanister 1902 and another valve can control delivery of the sealant 1500into the applicator tool 1908. After tissue T is stapled, such as bydeploying one or more cartridges of staples onto lung tissue, the distalend 1910 d of the shaft 1910 of the applicator 1908 can be positionednear the staples 1008 as in FIG. 35B. Preferably, the distal end 1910 dof the applicator tool 1908 is positioned about 5 to 30 mm away from astaple line depending on the size of the region to cover. A user cangrasp the handle assembly 1912 of the applicator tool 1008 and activatethe actuator 1914, such as by moving the pivotable lever 1914proximally. This can open a valve disposed in the system 1900 and begindelivering the gas 1920 to the canister 1902 to nebulize the sealant1500 so that it forms encapsulated liquid droplets that can be sprayeddirectly onto the tissue T, as shown. In this way, the sealant 1500 canbe delivered onto the tissue along the staple line, as shown in FIG.35C. The sealant 1500 can harden thereon, forming hardened regions 1500h facilitating formation and maintenance of a seal along the staples1008. The sealant 1500 can also be delivered onto an adjunct rather thandirectly onto the tissue T, such as any of the adjuncts describedherein. As will be appreciated by a person skilled in the art, sealantcan be delivered to any portion of the tissue, such as only the tissueat the staple line and/or beyond the staple line.

A sealant can be delivered in various ways. For example, a system 1900′for delivering a sealant 1500 is provided in FIG. 36A and includes manyof the features of FIG. 35A, including a gas source, canister, etc.However, in this embodiment the system delivers a nebulized sealant 1500directly through the trocar 1200 and does not include an applicatortool. In this embodiment, the system also need not include valves andthe delivery of the gas 1920 to the canister 1902 can simply becontrolled using a valve at the gas source. The delivery of gas into thecanister 1902 can also nebulize the sealant 1500, but rather than formencapsulated liquid droplets, the gas 1920 can be delivered at a higherpressure and rate to create a nebulized fog of sealant 1600. As shown inFIG. 36B, this sealant fog 1500 can spread throughout the chest cavityof the patient and can harden on all surfaces of the tissue, such asforming hardened regions 1500 h along all surfaces of the patient'slungs.

In an embodiment in which the sealant is blood, such as autologousblood, the blood can be harvested from the patient and applied to theadjunct material. By way of non-limiting example, the adjunct materialcan be ORC, a known hemostatic agent, and the application of the bloodto the ORC adjunct will cause the formation of a clot, resulting in aneffective sealing structure. A person skilled in the art will appreciatethat blood, such as autologous blood can be applied to a variety ofadjunct materials to provide an enhanced sealing structure. Further, aperson skilled in the art will appreciate that the volume of bloodapplied to the adjunct will vary depending upon a number of factors,including the type and location of tissue as well, the age and conditionof the patient, and the identity of the adjunct. Generally, however,when the adjunct is an ORC material, the blood can be applied in anamount in the range of about 5-10 cc per line of staple used to affixthe adjunct to the tissue.

Adjuncts Having Tissue Reinforcement Features

Adjunct materials described herein may be used in any suitable type ofsurgery where a surgical stapler or other instrument is deployed toconnect tissues. One advantage of tissue adjuncts is their propensity toprevent or minimize leaks, such as fluid or gas leaks. Tissue adjunctscan perform this function by one or more of the following mechanisms:plugging holes or tears that occur at the staple puncture sites;restricting movement of tissue around staple puncture sites to preventan increase in the size of staple holes and/or to prevent tissue tears;and minimizing strain gradients that occur between constrained tissueswithin the staple line and free tissue adjacent to the staple line.

In some embodiments, adjunct materials described herein may be used forsealing staple punctures created when a surgical stapler is used in lungsurgery. When surgery is performed on a lung, the lung is typicallycollapsed, and a required procedure, including application of thestapler to lung tissue, is then performed on the collapsed lung. Afterthe procedure is completed, the collapsed lung is reinflated to a normallung volume. The reinflation of the lung stretches the lung tissue(e.g., lung parenchyma), particularly in an area around a staple line,which may result in increased stress at a junction between the stapledtissue (which is restricted from stretching by the staples) and thesurrounding tissue areas. Furthermore, an airtight sealing is requiredfor the staple punctures of the lung. The sealing of a good quality maybe difficult to achieve—while leaks around staple punctures typicallyseal within approximately five days, in some cases, staple punctures maypersist for longer periods of time, such as, for example, six months orlonger. In such circumstances, a lengthy hospitalization of a patientmay be required.

Accordingly, applicants have recognized and appreciated that an endeffector, such as a staple cartridge assembly for use with a surgicalstapler, and/or its associated anvil, can include an adjunct materialwhich may be used to seal punctures created by a surgical stapler usedto secure lung or other types of tissue. The adjunct material can alsoreinforce the staple line, distribute stress load on the tissue near thestaple line, and minimize tearing of the tissue—e.g., when the lungtissue is reinflated after the surgery to transition to its normalvolume.

In some embodiments, the staple cartridge assembly can comprise acartridge body of a surgical stapler and an adjunct material, which isinterchangeably referred to herein as a tissue reinforcement construct.The tissue reinforcement construct can be removably attached to thecartridge body and is configured to be delivered to a surgical site bydeployment of the staples of the surgical stapler. When the staples aredeployed, the adjunct material can remain at the surgical site with thestaples. In this way, the adjunct material can be used to help sealholes formed by staples and/or can be used to provide tissuereinforcement at the treatment site.

In some embodiments, the adjunct material can comprise a first, orouter, dissolvable and/or absorbable material encompassing a second, orinner, material. The first material can be selectively dissolvableand/or absorbable. In some embodiments, the first material may bebrittle. The second material can be a swellable, hydrophilic materialthat is maintained within the first material in a constrainedconfiguration and is configured to transition to a predetermined shapewhen exposed to moisture in an unconstrained configuration. Prior todeployment of the staples, the second material can be encompassed withinthe first material in an intact form.

In some embodiments, the first material can be less hydrophilic than thesecond material and can therefore serve as a moisture barrier. Thesecond material may be compressed within the first material in aconstrained configuration such that, when the first material ispunctured by staples deployed to connect tissue or is otherwisepenetrated (e.g., cut by a surgical knife or compressed between acartridge and anvil), the second material is exposed to moisture fromthe surrounding environment of the patient's body and begins to swell.In this way, the second material gradually swells and expands toeventually transition to a predetermined shape. As the second innermaterial swells, it expands to seal the holes in the tissue created bythe staples. The second material can swell at a rate that allows it toform a seal around a hole as the tissue, such as lung parenchyma thatwas deflated prior to a surgical procedure, is inflated back to itsnormal volume, while compressing the stretching tissue and restrictingits deformation or preventing its tearing around the staple line.

In some embodiments, one or more portions of the first material, suchas, for example, portions encompassing peripheral edges of the secondmaterial can be more dissolvable than portions of the first materialencompassing a central portion of the second material. Additionally theportions of the first material encompassing the peripheral edges of thesecond material can be more absorbable than portions of the firstmaterial encompassing the central portion of the second material. Afterthe integrity of the first material is broken and as the portions of thefirst material encompassing the peripheral edges of the second materialare dissolved or absorbed by the patient's body, the second materialenclosed within those portion is allowed to expand upon exposure tomoisture to thus seal and reinforce the stapled tissue.

The first and second materials of the adjunct material may comprise anysuitable materials. In some embodiments, it is advantageous to select amaterial that is absorbable and capable of bearing compressive andbending loads. The first material can be formed from a variety ofmaterials. They may be present in continuous form so as to fullyencapsulate the materials making up the center of the device, oralternately they might be present in a non-continuous form. Thesenon-continuous forms include, but are not limited to, otherwiseencapsulating forms with minute openings allowing water or bodily fluidsto access the materials making up the center of the device to facilitaterapid hydration to allow expansion of the center material; melt blendnonwoven forms with controlled porosity; immiscible polymer blendshaving a major blend component an absorbable polymer and a minorcomponent being a biocompatible water soluble polymer which is capableof rapidly dissolving creating conduits to the central material allowingfor its rapid hydration to generate an external force on the tissue.

The absorbable polymer making up the outer layer, although not limitedto, can be selected from among polydioxanone (also referred to aspoly(1,4-dioxan-2-one), or poly(p-dioxanone)); polyglycolide (alsoreferred to as polyglycolic acid), polylactide (also referred to aspolylactic acid) in all its forms based on the ring-opening of thecorresponding lactone monomers, L(−)-lactide, D(+)-lactide, andmeso-lactide, as well as all of its forms based upon polycondensation ofL(+)-lactic acid and D(−)-lactic acid (e.g., poly(L(−)-lactide),poly(D(+)-lactide), poly(meso-lactide), poly(racemic-lactide),poly(L-lactic acid), poly(D-lactic acid), etc.); the polycaprolactones,especially poly(epsilon-caprolactone); polyhydroxyalkanoate (PHA); theabsorbable copolymers usually formed by the ring-opening polymerizationof the lactone monomers, L(−)-lactide, (D+)-lactide, meso-lactide,glycolide, 1,4-dioxan-2-one, trimethylene carbonate, and thecaprolactones, especially epsilon-caprolactone, in any molar combinationor in an sequential distribution. These later copolymers include, butare not limited to epsilon-caprolactone/glycolide copolymers such as25/75 poly(caprolactone-co-glycolide) (also referred to aspoliglecaprone 25), 10/90 poly(L(−)-lacide-co-glycolide) (also referredto as polyglactin 910), polyglyconate, polyglycolide-trimethylenecarbonate (PGA/TMC). The absorbable polymer can be a miscible orimmiscible blend of the previously mentioned polymers (and copolymersthereof) in any combination. In other embodiments, the first materialmay be selected from biodegradable synthetic absorbable polymers such asa polydioxanon film sold under the trademark PDS® or with a Polyglycerolsebacate (PGS) film or other biodegradable films formed from PGA(Polyglycolic acid and various forms thereof, marketed under thetrademarks Vicryl® and/or Neoveil®), PCL (Polycaprolactone), PLA or PLLA(Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25,sold under the trademark Monocryl®), PANACRYL® (Ethicon, Inc.,Somerville, N.J.), polyglactin 910, poly glyconate, PGA/TMC(polyglycolide-trimethylene carbonate sold under the trademark Biosyn),polyhydroxybutyrate (PHB), poly(vinylpyrrolidone) (PVP), poly(vinylalcohol) (PVA), absorbable polyurethanes, or a blend or copolymerizationof any of the above. Blends and/or copolymerizations of any of theaforementioned materials can be tailored to have a desired molecularweight and/or degradation rate. It will be clear to one skilled in theart to select a biocompatible material.

The second material may be formed from a variety of materials.Advantageous materials include those that are absorbable and can undergoa controlled degree of swelling so as to create an external force on thetissue. Swelling might be accomplished by hydration based on an influxof water or bodily fluids. One class of materials that is particularlyadvantageous is absorbable dehydrated hydrogels. These include thematerials described in U.S. Pat. No. 5,698,213, entitled “Hydrogels ofAbsorbable Polyoxaesters” and crosslinked aliphatic polyoxaesterscontaining amine and/or amido groups and blends thereof with otherpolymers as described in U.S. Pat. No. 5,700,583, each of which isincorporated herein by reference in its entirety. Other materialssuitable for the second material include water soluble polymers such aspoly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), andpolyethylene glycol (PEG) or the higher molecular weight polyethyleneoxide (PEO). Additionally suitable are absorbable polyurethanes. It isto be understood that suitable materials include copolymers that containa hydrophilic section and an absorbable polyester section; this wouldinclude, by way of example, the copolymer made by reaction of arelatively low molecular weight alpha,omega-dihydroxy polyethyleneglycol and a lactone monomer such as L(−)-lactide, (D+)-lactide,meso-lactide, glycolide, 1,4-dioxan-2-one, trimethylene carbonate, andthe caprolactones, especially epsilon-caprolactone, in any molarcombination or in an sequential distribution. Blends of materials andcopolymers formed from a wide variety of suitable monomers, some alreadymentioned above, may be suitable. In one embodiment, the second materialmay also be a biologically derived material as described above such asORC. It will be clear to one skilled in the art to select abiocompatible material.

The adjunct material described herein can be delivered to a treatmentsite using any suitable surgical stapling device, as embodiments are notlimited to any specific methods of employing a surgical stapling devicethat in used in conjunction with the adjunct material. In someembodiments, tissue is engaged between a cartridge assembly and an anvilof a surgical stapler at a treatment site, wherein at least one of thecartridge assembly and anvil has an adjunct material removably retainedthereon. The surgical stapler can then be actuated to eject staples fromthe cartridge assembly through the adjunct material and into the tissue.The adjunct material can help to reduce impact and trauma from thestapling and distribute stress load on the tissue near the staple lineto reduce the possibility of tissue tearing.

FIG. 37A illustrates an example of a portion 2000 of an end effector ofa surgical stapler that can be used with one or more adjunct materialsas described herein. In the example illustrated, the portion is a jaw2000 having a distal end 2002, a proximal end 2004 and a cartridge body2006. As shown in FIG. 37A, the surgical stapler includes a shaft 2008that can be configured to couple the end effector with a handle assemblyof the surgical stapler which is not shown for ease of illustration.

The jaw 2000 of the surgical stapler can be configured to supportstaples 2010 which can be arranged in any suitable configuration. Inthis example, the staples 2010 are arranged in rows and create a stapleline when deployed to engage tissue. However, it should be appreciatedthat the staples 2010 may be arranged in a circular or any otherconfiguration, as embodiments are not limited in this respect.

As shown in FIG. 37A, the jaw 2000 serving as a cartridge assembly canbe associated with an adjunct material 2012, also referred tointerchangeably herein as a tissue reinforcement construct. The adjunctmaterial 2012 can be removably retained on the cartridge body 2006 so asto be positioned over the staples 2010 in any suitable manner. In someembodiments, the cartridge body 2006 can be preloaded with an adjunctmaterial such as the material 2012. In other embodiments, the adjunctmaterial 2012 can be positioned on the cartridge 2006 (e.g., by asurgeon or other medical professional) prior to a surgical procedure.

The adjunct material 2012 can have a configuration such that at leastone of peripheral edge portions 2014A and 2014B has a cross section thatis larger than a cross-section of a central portion 2016 the adjunctmaterial 2012. The central portion 2016 of the adjunct material 2012 canbe defined as a portion that is closer to a longitudinal axis of thecartridge body 2006 than the peripheral edges of the cartridge body. Thecentral portion 2016 and the peripheral edge portions 2014A and 2014Bcan have any suitable widths. Moreover, the peripheral edge portions2014A and 2014B can have the same or different widths.

In should be appreciated that the tissue reinforcement construct inaccordance with some embodiments can be advantageously used to reinforcea staple line created by the surgical stapler with improved qualityrelative to existing approaches. For example, in some embodiments, thetissue reinforcement construct can be used to reinforce the staple line270 degrees around its perimeter. In particular, referring to FIG. 37A,the adjunct material 2012 can be configured such that the peripheraledge portions 2014A and 2014B and a distal portion 2015 have propertiessuch that the staple line created by the staples 2010 can be reinforced.For example, the larger cross-section of the peripheral edge portions2014A and 2014B makes the adjunct material able to reduce or preventdamage to tissue—e.g., to sensitive tissue in thoracic cavity. Further,in some embodiments, the peripheral edge portions 2014A and 2014B andthe distal portion 2015 can be more flexible or stretchable than thecentral portion 2016 of the adjunct material 2012, which can furtherhelp to compress tissue such as the lung parenchyma as it is reinflatedafter surgery. Additionally or alternatively, in some embodiments, someor all of the peripheral edge portions 2014A and 2014B and the distalportion 2015 can degrade at a faster rate than the central portion 2016,which can lead to a faster rate of release of the inner material of theadjunct material 2012 encompassed within those portions. In this way,tissue in the area around the staple line can be reinforced in anatraumatic way almost immediately after the tissue is penetrated by thestaples and/or a knife.

It should be appreciated that the adjunct material 2012 can have anyother features that facilitate its use with the surgical stapler. Forexample, in some cases, the adjunct material 2012 can have cut-out tabsthat can be pressed or slid into a knife slot or cartridge of thesurgical stapler. When the knife cuts down in the middle of the adjunctmaterial, the tabs are cut out and separated from the stapler.

FIG. 37B illustrates an enlarged view 2100 of a cross section 2018 of aportion of the adjunct material 2012 of FIG. 37A. As shown in FIG. 37B,a peripheral edge, such as, for example, the peripheral edge 2014A, mayhave a larger cross sectional dimension than that of the central portion2016. The larger cross sectional thickness of the edge portion allows tobetter seal the areas around the holes created by the staples andprevent tissue tearing. As shown in FIG. 37A, the adjunct material 2012can be releasably positioned on the cartridge body 2006 so that one orboth of the peripheral edge portions 2014A and 2014B extend beyond thecartridge body 2006. This can further improve the way in which theadjunct material 2012, when in an unconstrained configuration uponexposure to moisture, expands and provides effective sealing of a stapleline created by the surgical stapler against air or fluid leakage andprevents tearing of the tissue near the staple line.

In some embodiments, the adjunct material 2012 may comprise an outermaterial that encompasses an inner material maintained within the outermaterial in a constrained configuration. FIG. 38 shows by way of examplethat the adjunct material 2012 can comprise a first, outer material 2022and a second, inner material 2024. The first material 2022 may be asuitable dissolvable and/or absorbable material. The second material2024 may be a suitable hydrophilic, swellable material. The propertiesof the first and second material may be uniform throughout or may vary.For example, the first material 2022 may be selectively dissolvableand/or absorbable. Similarly, different portions of the second material2024 can have different hydrophilicity. For example, in some cases,peripheral edge portions of the second material 2024 can be morehydrophilic than a central portion of the second material 2024.

The first material 2022 may envelop the second material 2024 and, priorto delivering staples (e.g., staples 2010 in FIG. 37A) to the tissue,serve as a moisture barrier. The first material 2022 may be at leastpartially stretchable or may have any other properties that can beselected based on a clinical application of the adjunct material. Forexample, in some embodiments, the first material 2022 may be at leastpartially brittle.

The first material 2022 can prevent exposure of the second material 2024to moisture for a certain time period—e.g., until the adjunct material2012 is delivered to the surgical site in the patient's body. When thestaples are deployed and the adjunct material 2012 is thus pierced orotherwise penetrated, the second material 2024 begins to swell uponexposure to moisture that passes to the second material 2024 throughpunctures in the first material 2022. Additionally or alternatively, thefirst material 2022 can be cut by a knife of the surgical stapler uponits deployment. Furthermore, in some embodiments, the properties of thefirst material 2022 may be such that the material can crack or otherwiselose its integrity due to compression when it is pressed between thecartridge and anvil of the surgical stapler. For example, if the firstmaterial 2022 is brittle, it can be broken by compression.

As discussed above, the first and second materials can be made from anumber of suitable biologic materials and/or synthetic materials.

In some embodiments, the first and second material may be selected suchthat the first material is less hydrophilic than the second material.The same materials (e.g., polymers) may be used to manufacture the firstand second materials, but the molecular weight of the source materialsmay be adjusted differently to produce materials suitable for the firstmaterial and materials suitable for the second material. The molecularweight of the polymers can be altered so that to obtain materials havingdesired degradation properties, as discussed above. For example,mixtures of PGA (Polyglycolic acid and various forms thereof, marketedunder the trademarks Vicryl® and/or Neoveil®), and PLA or PLLA(Polylactic acid) can absorb at a relatively fast rate. Similarly,polyhydroxyalkanoate (PHA) can dissolve quickly and the materials madefrom PHA can begin to degrade within 20 to 30 minutes after attachmentto tissue via contact with heat and/or water.

The degradation rates of the first and second material may be selectedbased on the desired clinical application—e.g., based on a type oftreated tissue and/or an amount of time that the adjunct material isdesired to remain at the surgical site. For example, a first materialfor an adjunct material intended to be used in lung surgeries may have aslower degradation rate than that of a first material for the adjunctmaterial to be used to staple vessels. It should be appreciated,however, that embodiments are not limited to materials having anyspecific degradation rates or any other properties.

FIG. 39 illustrates the second material 2024 that can be maintainedwithin the first material 2022 in a constrained configuration—e.g., in acompressed or otherwise constrained configuration. In some embodiments,the second material 2024 can be a hydrophilic foam. The second material2024 may comprise any suitable material(s) and, in some embodiments, mayinclude one or more therapeutic agents, such as, for example, drugs,promoters of healing, antibacterial agent(s), and antimicrobialagent(s). The therapeutic agent can be configured to be released overtime to aid the tissue in healing, for example. In embodiments wheremore than one therapeutic agent is employed, different therapeuticagents can be configured to release at different rates.

Upon exposure to moisture schematically shown in FIG. 39 as moisture2026, the second material 2024 can absorb moisture and thus swell andexpand. Additionally, if the second material 2024 includes one or moretherapeutic substance(s), these substances can begin to elute once thesecond material 2024 is exposed to moisture. The moisture 2026 can beblood, other bodily fluid, or any other liquid. The adjunct material2012 can be manufactured such that one or more portions of the secondmaterial 2024, can, upon exposure to moisture, expand to transition to apreconfigured shape. The shape of the second material 2024 prior to andafter exposure to moisture can be selected so as to provide a goodquality seal around the punctures in the tissue created by the staplesand provide reinforcement to the staple line against the tissue toprevent tears in the tissue or pulling of the staples through thetissue. For example, as illustrated in FIG. 39, the second material 2024can have a shape such that its peripheral edges have a largercross-section than its central portion.

Although FIGS. 37A-39 illustrate the adjunct material 2012 having ashape such that the peripheral edges portions have a largercross-section than that of the central portion of the adjunct material,it should be appreciated that the adjunct material 2012 can have anysuitable shape, as embodiments are not limited in this respect. Forexample, the adjunct material can have a uniform thickness throughout,or the thickness of the adjunct material can vary in any suitablemanner. Regardless of the shape and size of the adjunct material, insome embodiments, the adjunct material can be configured such that oneor more portions of the first material are selectively dissolvableand/or selectively absorbable by the patient's body. Furthermore, one ormore portions of the second material can be selectively swellable.

FIG. 40 is a side view of the adjunct material 2012 removably attachedto the cartridge body 2006, prior to deployment of staples supported bythe cartridge body 2006. The first material 2022 of adjunct material2012 comprises a top layer 2028 and a bottom layer 2030, with the secondmaterial 2024 sealably enclosed therebetween. As illustrated, aperipheral edge portion of the adjunct material 2012 extends beyond thecartridge body 2006. Such disposition of the adjunct material 2012 withrespect to the cartridge body 2006 enhances tissue reinforcement andoffers improved resistance to air and fluid leaks around staple holes.

In some embodiments, adjunct materials as described herein may be usedin a surgical stapling device that is employed in lung surgery, such asin surgery to treat lung cancer, lung volume reduction surgery, or anyother type of surgery. Prior to such surgery, the lung is deflated, andthen reinflated to its normal volume after the required procedure iscompleted. A common complication after such a surgery is that air orfluid can leak though the punctures or holes created by the staples.Moreover, as the lung is being reinflated and the tissue stretches,holes can increase in size (through stretching) or tears can occur inthe tissue areas around the staple holes. Accordingly, the describedadjunct material can be used to reinforce the tissue around the stapleholes and compress the tissue as the lung stretches to assume its normalvolume. It should be appreciated, however, that the adjunct material canalso be used to seal punctures created by surgical staplers used tosecure any other type of tissue, such as, gastrointestinal tissue andvessels (e.g., intestine, stomach and esophagus).

Additionally, in some embodiments, an adjunct material can comprise oneor more therapeutic substances, or agents, that can be eluted when thestaples are deployed to help healing the tissue at the treatment site,or to prevent or combat infection. The therapeutic substances can bereleased at different rates to provide the desired action at thetreatment site.

In some embodiments, either or both of the cartridge and anvil of theend effector of a surgical stapler can have removably attached theretoan adjunct material such as, for example, the adjunct material 2012.Accordingly, FIGS. 41A and 41B show that two adjunct materials 2100 and2102 can be used with the surgical stapler to reinforce tissue at atreatment site. When the staples (e.g., staples 2010A-2010C in FIGS. 41Aand 41B) are deployed to engage tissue 2104, each of them can create acorresponding puncture in the adjunct material. FIGS. 41A and 41Billustrate by way of example punctures 2106 in the adjunct material2100. It should be appreciated, however, that the adjunct material 2102is similarly punctured by the staples 2010A-2010C. In addition, itshould be appreciated that only three staples 2010A-2010C are shown forthe purpose of illustration only, as embodiments are not limited to anyspecific number of staples that can be seated in the cartridge body.

The staples deployed to engage the tissue can remain with the tissueuntil they are removed using an instrument, absorbed by the patient'sbody or otherwise removed from the treatment site. The adjunct materialis maintained at the treatment site by the staples for a certain periodof time which can depend on a number of factors—e.g., a period duringwhich the staple holes are expected to heal, a time required for one ormore portions of the adjunct materials to disintegrate, and any othersuitable factors. Furthermore, one or both of the first and secondmaterials of the adjunct material can be dissolvable and/or(bio)absorbable materials that are gradually absorbed or eliminated inother ways from the patient's body.

FIG. 41A shows the staples 2010A-2010C retaining the adjunct materials2100 and 2102 at the treatment site of the engaged tissue 2104 at aperiod of time shortly after the staples are deployed. Because thestaples 2010A-2010C penetrate the adjunct materials 2100 and 2102, theintegrity of the first layer of the adjunct materials is disturbed, andmoisture can pass to activate the second material 2024 encompassedwithin the first material 2022.

In some embodiments, as shown in FIG. 41B, after a certain time period(which can be of any suitable duration), tissue 2104 begins toexpand—e.g., lung parenchyma expands to eventually reach its normalvolume, after a surgery was performed on a collapsed lung. At the sametime, the second material 2024, which can be hydrophilic, begins toswell upon contact with moisture. As the tissue 2104 expands, the secondmaterial 2024 can swell gradually, to transition to a large radius(denoted by way of example using reference numeral 2108 in FIG. 41B) atperipheral edges portions 2109 and 2111 of the adjunct materials 2100and 2102, respectively.

The first material 2022 encompassing peripheral edge and distal portionsof the second material 2024 can stretch to accommodate the expandingvolume of the second material 2024. Further, one or more portions of thefirst material 2022 can be dissolvable and/or absorbable so that thefirst material 2022 gradually disintegrates as the second material 2024swells and expands from its constrained form to a predefined shape. Inparticular, in the embodiment of FIG. 41B, the portions of the firstmaterial 2022 at the peripheral edge portions 2109 and 2111 can beconfigured to dissolve at a faster rate than portions of the firstmaterial encompassing a central portion of the second material 2024.Additionally or alternatively, the portions of the first material 2022at the peripheral edge portions 2109 and 2111 can be configured toabsorb at a faster rate than portions of the first material encompassingthe central portion of the second material 2024. The describedconfiguration of the first material, where the staple holes in thetissue are sealed and the tissue area surrounding a large portion of thestaple line is compressed by the swollen hydrophilic material allowsreinforcing the tissue in an effective, atraumatic manner. In this way,the sensitive lung tissue can be sealed so as to prevent bleeding,tearing, and/or leakage of the treated tissue. The ability to create anairtight seal while allowing the tissue to safely stretch around thestaple line (e.g., as the lung is reinflated) is particularly usefulbecause the success of the patient's recovery is largely based on howfast the tissue at the surgical site can heal.

As discussed above, in some embodiments, the first, outer material ofthe adjunct material described herein can have properties that are notuniform throughout. For example, as also discussed above the firstmaterial may be selectively dissolvable and/or selectively absorbable.In some embodiments, one or more portions of the first material can beadapted to dissolve at a faster rate than other portions of the firstmaterial. Additionally or alternatively, one or more portions of thefirst material can be adapted to absorb at a faster rate than otherportions of the first material. The portions of the first material thatare adapted to dissolve and/or absorb at a faster rate can be, forexample, peripheral edge portions of the first material, or any otherportions.

FIG. 42A illustrates an example of a first material 2201 of an adjunctmaterial 2200 that has portions 2202 adapted to dissolve and/or absorbat a faster rate than portions 2204 of the first material 2200. In thisexample, the adjunct material 2200 has a uniform, or approximatelyuniform, thickness throughout. However, it should be appreciated thatthe thickness of the adjunct material can vary from one portion toanother. It should also be appreciated that the alternating portions2202 and 2204 are shown by way of example only, as the first materialcan be partitioned into the portions having different dissolution ratesand/or portions having different absorption rates in any suitablemanner. For example, as mentioned above, the portions of the firstmaterial encompassing the peripheral edge portions of the secondmaterial can be adapted to dissolve at a faster rate than portions ofthe first material encompassing the central portions of the secondmaterial.

Furthermore, the portions of the first material encompassing theperipheral edge portions of the second material can be configured toabsorb at a faster rate than portions of the first material encompassingthe central portions of the second material. Additionally, the portions2202 and 2204 can have different widths, as embodiments as not limitedin this respect. By varying the number, length, width and otherproperties (e.g., materials) of the portions of the first materialconfigured to dissolve and/or absorb at different rates, the secondmaterial can be configured to expand at different rates. Differentmaterials can be selected for the first and second materials to obtaindesired degradation rates. Depending upon the desired clinicalapplication, different rates at which the second material swells andexpands can be controlled to distribute load around the staple line anddecrease the possibility of tissue tearing. Additionally, a time duringwhich the adjunct material remains at the treatment site can be adjustedby varying properties of the first and second materials.

FIG. 42B shows an enlarged cross-sectional view of a portion 2208 of theadjunct material 2200 of FIG. 42A. The first material 2201 of theadjunct material 2200 encloses the second material 2206 which may be ahydrophilic foam comprising any suitable material. Similar to FIG. 42A,FIG. 42B also demonstrates that the first material 2201 can compriseportions 2202 configured to dissolve and/or absorb at a faster rate thanportions 2204. It should be appreciated that FIG. 42B shows thatportions 2202 located on different sides of the second materials 2206(e.g., portions 2202A and 2202B) are shown to be aligned with each otherby way of example only, as embodiments are not limited in this respect.

FIG. 43 illustrates an example in accordance with some embodiments whereboth a cartridge and anvil side of the surgical stapler can have anadjunct material removably retained thereon. Accordingly, in thisexample, adjunct materials 2400 and 2402 (e.g., adjunct materials 2200or any other suitable adjunct materials) are employed to seal puncturesin tissue 2404 created by the staples 2010. As shown, when the adjunctmaterials 2400 and 2402 are pierced by the staples 2010, moisture 2026from the surrounding environment (e.g., blood, other bodily fluid,water, medication, etc.) passes through the staple holes (e.g., a hole2408 in FIG. 44) to the inner hydrophilic material (e.g., the secondmaterial 2206 of FIGS. 42A and 42B) maintained within an outer layer ofthe adjunct material.

FIG. 43 also shows that peripheral edge portions of the adjunctmaterials which, prior to deployment of the staples, extend beyond thecartridge body and/or anvil, can transition to a large radius which mayreinforce the tissue 2404. In particular, a peripheral edge portion 2403of the adjunct material 2400 can transition to a large radius 2405. Forexample, the portion 2403 can transition from a radius roughly equal tohalf the thickness of the adjunct (about 0.025 to 1.0 mm) to a radius upto about 5 times the initial size of the feature. However, it should beappreciated that the adjunct material described herein can have anysuitable dimensions and, when in an unconstrained form, can transitionto a radius of any suitable size, as embodiments are not limited in thisrespect.

Additionally, a portion of a first material of the adjunct material 2400(e.g., the first material 2201 of FIGS. 42A and 42B) at the peripheraledge portion 2403 can be such that it dissolves and/or absorbs at afaster rate than other portions of the first material. In this way, theperipheral edge portion 2403 of the adjunct material can disintegratefaster than other areas of the first material, thus allowing the secondmaterial encompassed within that portion to swell and expand at a fasterrate than the central portion of the second material. As discussedabove, the adjunct materials can expand to transition to a predeterminedshape, which can be selected based on a clinical application, type ofwound to be sealed, and any other factors.

Additionally, because the outer layer of the adjunct material, such as,for example, the first material 2201, can be at least partiallyhydrophilic and/or absorbable, one or more portions of this layer, whichmay or may not be pierced by a staple, can begin to disintegrate asindicated by reference numeral 2410, as schematically shown in FIG. 44upon exposure to moisture 2026.

The adjunct material described herein may comprise a first material,which is a material encompassing a second material, that can havevarious properties. For example, as discussed above, the first materialcan have portions that dissolve at different rates, portions that absorbat different rates, portions of varying widths, etc. The first andsecond materials can comprise different materials.

An adjunct material 2500 shown in FIG. 45 may have a thickness that isthe same or substantially the same along a cross-section of the adjunctmaterial. In this example, a first (outer) material 2502 of the adjunctmaterial 2500 may be brittle. It should be appreciated, however, thatthe adjunct material in accordance with some embodiments having anysuitable shape can be brittle.

The first material 2502 can encompass a second material 2504 which maybe a hydrophilic foam made of any suitable material. Additionally, insome embodiments, the second material 2504 may comprise one or moretherapeutic substances. The non-limiting examples of the therapeuticsubstance include fibrin, thrombin, antibiotics, antimicrobial, andantibacterial agents. Suitable agents can include, but are not limitedto, triclosean, and silver and copper ions and nanoparticles. It shouldbe appreciated that any number of any suitable therapeutic substancescan be included with the second material 2504 and can be eluted with thesecond material 2504 is exposed to moisture and/or heat in the patient'sbody.

In some embodiments, tissue is engaged between a cartridge assembly andan anvil of a surgical stapler at a treatment site, wherein at least oneof the cartridge assembly and anvil has an adjunct material removablyretained thereon. The surgical stapler can then be actuated to ejectstaples from the cartridge assembly through the adjunct material andinto the tissue. The adjunct material can help to reduce impact andtrauma from the stapling, distribute stress load on the tissue near thestaple line—e.g., as the tissue such as lung parenchyma is stretchedafter the surgery to its normal volume. It should be appreciated,however, that the adjunct material described herein can be employed inany type of surgery, and embodiments are not particularly limited tolung surgeries.

In the example illustrated in FIG. 46, an adjunct material 2500 can bepositioned on a tissue facing side 2602 of an anvil 2604 of a surgicalstapler. When staples 2606 supported by a cartridge body 2608 (which maybe similar to the cartridge body 2006 in FIG. 37A) are deployed toengage tissue 2610, the first material 2502 of the adjunct material 2500can fracture so as to expose the second material 2504 to moisture.Additionally or alternatively, the adjunct material 2500 can fracture bybeing compressed between the anvil 2604 and the cartridge assembly 2608.Furthermore, in embodiments as shown in this example in which thesurgical stapler includes a knife 2612, the knife 2612 can also be usedto cut the adjunct material 2500 thus exposing the second material 2504to moisture. Although adjunct material 2500 is shown in FIG. 46 as beingdisposed on an anvil 2604 of a surgical stapler, adjunct material 2500may be placed on one or both tissue facing surfaces of opposed jaws of asurgical stapler.

Regardless of the way in which the second material 2504 of the adjunctmaterial 2500 is exposed to moisture, the second material 2504 expandsto seal staple holes or prevent them from forming and the therapeuticsubstance is released to provide the desired effect on the tissue 2610,as shown in FIG. 47.

Woven Adjunct Materials

Adjunct materials are provided for sealing of a staple line againstfluid leakage. One advantage of tissue adjuncts is their propensity toprevent or minimize leaks, such as fluid or gas leaks. Tissue adjunctscan perform this function by one or more of the following mechanisms:plugging holes or tears that occur at the staple puncture sites;restricting movement of tissue around staple puncture sites to preventan increase in the size of staple holes and/or to prevent tissue tears;and minimizing strain gradients that occur between constrained tissueswithin the staple line and free tissue adjacent to the staple line.

A woven adjunct material can provide reinforcement to the staple lineand can prevent tears in the tissue or pulling of the staples throughthe tissue by distributing stress along the tissue near a staple line.Further, a woven adjunct material can absorb impact from stapling andreduce trauma at and/or beyond the staple line. In certain aspects, thewoven adjunct material can act as a medium into which staples canpenetrate into when tissue at the staple site is thin or diseased. Awoven adjunct material can thus be configured to both distribute thecompressive load and to compensate for variable tissue thickness. Incertain aspects, an adjunct material can include a plurality of layers,at least one of which is woven, such as a core and one or more layers. Asize, shape, and a composition of the material forming each these layerscan be selected in various ways to influence mechanical properties ofthe resulting adjunct material, such as a compressibility and fluidabsorption capability of the adjunct.

An adjunct material can be inserted into a patient and deployed at asurgical site in various ways. For example, an adjunct material can bereleasably coupled to an end effector of a surgical stapler, the endeffector including a cartridge assembly and an anvil. When the endeffector is positioned adjacent to a surgical site, tissue can beengaged between the cartridge assembly and the anvil. Actuation of thesurgical stapler can eject staples from the cartridge assembly, throughthe adjunct material, and into the tissue grasped between the jaws. Theadjunct material can help to reduce trauma from the stapling anddistribute stress load across the tissue near the staple line to reducea likelihood that the tissue will tear. In certain aspects, the adjunctmaterial can elute a therapeutic agent, serve to absorb fluid, adjustfor variations in material thickness, or perform various other functionswhen the adjunct is deployed onto tissue.

A woven adjunct material can have various sizes, shapes, andconfigurations. In one embodiment, a woven adjunct material includes aninner core layer and at least one outer layer of material. The outerlayer of material can be positioned on one or more sides of the corelayer, e.g., top, bottom, and/or lateral sides of the core layer. In oneembodiment, a flexible support layer can surround all sides of theelastic core layer so as to envelop the elastic core. The core layer andflexible support layers can be formed from various materials. Forexample, the elastic core layer can be a layer of loosely wovenmaterial, and a tightly woven material can surround the elastic corelayer on at least one side and can act as a flexible support layer. Eachof the flexible support layers can include fibers 3004, which can be thesame as or different than fibers 3005 in the elastic core layer 3003.FIG. 48B illustrates one exemplary embodiment of a woven adjunctmaterial 3000 in which flexible support layers 3001, 3002, arepositioned on the top and bottom of the elastic core layer 3003,respectively.

The woven adjunct material can be configured to releasably couple to anend effector of a surgical instrument, such as a cartridge assemblyand/or anvil of a surgical stapler. For example, FIG. 48A shows thewoven adjunct 3000 including the two flexible support layers 3001, 3002on the top and bottom of the elastic core layer 3003 and coupled to acartridge assembly 3060 having a knife slot 3067 and a plurality ofstaple cavities (not shown). The woven adjunct can be releasablyretained on any of the end effectors of the surgical staplers providedherein e.g., staplers 10, 100, 200, an open linear cutting stapler.

The adjunct material can deliver various benefits to the tissue when theadjunct material is stapled to the tissue. FIG. 48C shows the effects ofan adjunct material A on a tissue T. As illustrated in FIG. 48C, theadjunct material A can compensate for variable thickness of the tissueat the staples S by compressing under the load of the staples S. Theadjunct material A can distribute a strain on the tissue T from thestaples S to a portion of the tissue T positioned beyond the staple lineto prevent tearing along the tissue T at or beyond the staple line.

FIGS. 49A-C show a behavior of an adjunct material 3000 when acompressive force is applied and then released. More specifically, FIG.49A shows the adjunct material 3000 before application of a compressiveforce. FIG. 49B shows the adjunct material 3000 having a compressiveforce applied thereto which decreases a thickness of the adjunct. FIG.49C shows the adjunct material 3000 after the compressive force isreleased therefrom, which increases a thickness of the adjunct. Thiscompression and expansion capability can result from the structure ofthe adjunct material.

The support layer(s) of the woven material 3000 can be formed in avariety of weave patterns and geometries to provide desired mechanicalproperties, such as flexibility, pressure distribution, homeostasis, andpneumostasis. The weave pattern used to form support layer(s) can varyand can include, by way of non-limiting example, those achieved by flatknitting processes with various needles, circular knitting processeswith various needles, double knitting, warp knits, weft, knits, plainweaves, pile weaves, etc. The flexible support layer 3001, 3002 and theelastic core layer 3003 can have the same weave pattern or the flexiblesupport layer and the elastic core layer can have different weavepatterns to achieve a desired property for each layer. Additionalprocesses can be applied to a layer to adjust its size, density,mechanical properties, surface properties, appearance, etc. Theseprocesses include the application of heat, the application of heat undera boundary condition such as force or displacement, a chemical treatment(e.g., scouring, mercerizing, singeing, raising, calendaring,sanforizing, etc.). A person of skill in the art will appreciate thatthe structure of the flexible support layer(s) of the woven adjunct canbe adjusted to achieve desired properties. For example, the flexiblesupport layer(s) can have a tighter weave than a weave of the corelayer. In certain aspects, the flexible support layer(s) can be denselywoven. Regarding a relative density of the support layer and the corelayer, the support layer(s) can be in the range of about 2 to 10 timesmore densely woven than the elastic core layer.

FIG. 50 illustrates an exemplary weave of fibers used to form thesupport layers 3001, 3002 of FIGS. 48A-48C. As shown, fibers 3004 can bewoven into loops which interlock in both the X and Y directions. A weavedensity of the flexible support layers 3001, 3002 can be sufficientlydense so that the support layers 3001, 3002 are not transparent tolight. The weave density can be characterized in various ways, such asby a degree of binding between adjacent fibers. The fibers can beinterlocked, as shown, or knotted together, such that there issubstantially no relative motion between the fibers when a force isapplied to the layer. Fibers 3004 may be comprised of a braided mix ofmultiple smaller fibers made of one or more materials. The selection ormaterials, fiber diameter, and ratios of different fiber constituents(e.g., five fibers of a first material for every one fiber of a secondmaterial) can impact the behavior of fibers 3004.

One skilled in the art will appreciate that the flexible supportlayer(s) 3001, 3002 can be formed from various types of fibers that arebiocompatible and bioabsorbable. Examples of such materials includevarious materials from which sutures are made, including naturallyoccurring fiber materials and synthetic fibers. Exemplary materialsinclude polydioxanon (sold under the trademark PDS®), Polyglycerolsebacate (PGS), PGA (Polyglycolic acid and various forms thereof,marketed under the trademarks VICRYL® and/or NEOVEIO, PCL(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(Polyhydroxyalkanoate), PGCL (Poliglecaprone 25, sold under thetrademark MONOCRYL®, PANACRYL® (Ethicon, Inc., Somerville, N.J.),polyglactin 910, polyglyconate, PGA/TMC (polyglocolide-trimethylenecarbonate sold under the trademark BIOSYN®), polyhydroxybutyrate (PHB),poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), absorbablepolyurethanes, regenerated cellulose, and oxidized regenerated cellulosefibers (ORC). Blends and/or copolymerizations of any of theaforementioned materials can be tailored to have a desired molecularweight, mechanical properties, and/or degradation rate. In oneembodiment, the flexible support layers(s) 3001, 3002 can be formed as anon-woven structure derived from the aforementioned materials. Thesematerials may be in the form of a foam and/or film. In one embodiment,the flexible support layers(s) are at least partially comprised of PDS®to facilitate adherence to elastic core layer 3003. In one embodiment,fiber 3004 is a braided filament comprised of five Vicryl® fibers andone PDS® fiber.

In one embodiment, the flexible support layer(s) 3001, 3002 can beformed from a combination of synthetic fibers and naturally occurringfibers. For example, a naturally occurring fiber or fibers can be woveninto the tissue contacting surface of a flexible support layer primarilycomprising synthetic fibers. Exemplary naturally occurring materialsinclude oxidized regenerated cellulose fibers (ORC) and regeneratedcellulose. The naturally occurring material, particularly ORC, can beadvantageous as it can function to form a seal with the tissue as ittends to gelatinize upon contact with a liquid.

A size of the fibers in the flexible support layer(s) can be selected toachieve desired mechanical properties. An exemplary composition of theflexible support layer is fibers 3004 in the support layer(s) can be inthe range of about 10-0 to 24-0 in size, i.e., about 0.024 mm to 0.3 mm.In addition, the fibers of the flexible support layer(s) can be ofvarious fiber types including monofilament and braided.

The elastic core layer 3003 can have various sizes, shapes, andconfigurations, and the material of the elastic core layer can beselected to achieve desired mechanical properties. The elastic corelayer 3003 can include a knitted or woven structure that is loose in onedirection (the direction of deformation) that readily compress when acompressive force is applied and then can expand when the compressiveforce is no longer applied. Increasing resistance to compression (in thedirection of deformation) can be achieved by compacting the structure inthe plane perpendicular to the direction of primary deformation. Thiscompact structure can be achieved by post-knitting process steps such asheating, mechanical compression, etc. Further, the fibers in the elasticcore layer can be loosely woven such that the fibers are able to moverelative to one another more readily than the interlocked or knottedfibers in the support layer. As such, the weave density of the elasticcore layer 3003 is typically significantly less dense in at least onedirection than that of the support layers 3001, 3002. By way of example,the relatively low weave density of the elastic core layer 3003 can becharacterized in terms of the weave density being sufficiently low so asto permit it to be transparent to light. An alternative descriptionwould be a deformation inducing a stretch ratio of approximately 0.5requires a pressure of approximately 3 g/mm².

Like the flexible support layer(s), the elastic core layer can be formedfrom various types of fibers that are biocompatible and bioabsorbable.Examples of such materials include various materials from which suturesare made, including naturally occurring fiberous materials and syntheticfibers. Exemplary materials include polydioxanon (sold under thetrademark PDS®), Polyglycerol sebacate (PGS), PGA (Polyglycolic acid andvarious forms thereof, marketed under the trademarks VICRYL® and/orNEOVEIL®), PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(Polyhydroxyalkanoate), PGCL (Poliglecaprone 25, sold under thetrademark MONOCRYL®, PANACRYL® (Ethicon, Inc., Somerville, N.J.),polyglactin 910, polyglyconate, PGA/TMC (polyglocolide-trimethylenecarbonate sold under the trademark BIOSYN®), polyhydroxybutyrate (PHB),poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), absorbablepolyurethanes, regenerated cellulose, and oxidized regenerated cellulosefibers (ORC). Blends and/or copolymerizations of any of theaforementioned materials can be tailored to have a desired molecularweight, mechanical properties, and/or degredation rate. In oneembodiment, the elastic core layer 3003 can be at least partiallycomprised of PDS® to facilitate adherence to flexible support layer(s)3001, 3002. In one embodiment, fiber 3005 is a braided filamentcomprised of five Vicryl® fibers and one PDS® fiber.

A size of the fibers in the elastic core layer can affect the propertiesof the adjunct material, such as elasticity, compressibility, andresiliency of the adjunct. In one embodiment, the fibers in the elasticcore layer 3005 can have a greater diameter than the fibers in theflexible support layers 3004. The fibers of the elastic core can bebraided or can be a monofilament. While a size of the fiber forming theelastic core can vary, in one embodiment the elastic core can be formedfrom fibers made of suture materials having a size in the range of about10-0 to 2-0 in size, i.e., about 0.02 mm to 0.3 mm.

The elastic core layer and the flexible support layer(s) can beconnected in various ways. For example, the elastic core layer andflexible support layer(s) can be directly connected, e.g., woventogether. As shown in FIGS. 51A and 51B, the fibers 3004 of the flexiblesupport layers 3001, 3002 can be woven around and interlocked with thefibers 3005 of the elastic core layer 3003. In another embodiment, (notshown), the elastic core and flexible support layers can be bondedtogether my melting one or more constituents (e.g., PDS®, etc.)comprising fibers 3004 of the flexible support layers 3001, 3002 andfibers 3005 of the elastic core layer 3003. In another embodiment (notshown), the elastic core and flexible support layers can be bondedtogether using any known manufacturing technique, such as using feltingor otherwise adhering the layers together.

A thickness of an adjunct material, including the elastic core and theflexible support layer(s), can vary depending on the intended clinicalapplication. In general, an adjunct material can be at least as thick asa height of a staple in its formed state. If a single adjunct materialis coupled to one portion of an end effector, e.g. a cartridge assemblyor an anvil, the adjunct material can be about 3.5 mm thick.Alternatively, if an adjunct material is present on both the anvil andthe cartridge, each piece of adjunct material can be about one half ofthe height of the staple in its formed state. The flexible supportlayers typically have a thickness equal to about the diameter of two ofthe fibers used for the flexible support layer, typically from about0.16 to 0.6 mm thick. The elastic core typically comprises the remainderof the thickness dimension of the adjunct material. Generally, thethickness of the elastic core can be in the range of about 2 to 3 mm.

Woven three-dimensional structures can be formed in such a way and usingsuch materials that they will have desired mechanical properties. Theadjunct material generally will have a number of desired properties thatwill vary depending upon the claimed application. One of skill in theart will understand that the material can be varied in accordance withthe description above to modify these desired properties. Typically,however, when compressed and held at a height of 2 mm in a 37° C. PBSsolution, the adjunct material construct can provide a minimum pressureof 3.0 gf/mm² from the time of compression (t=0) through 72 hours. Whencompressed and held at a height of 2 mm in a 37° C. PBS solution, theadjunct material construct can provide pressure that does not go belowthe line defined by 3.0 gf/mm² @ 72 hours and 0.0 gf/mm² at day 28. Whencompressed to 1.0 mm, held for 15 seconds, and then released, theadjunct material can return to 2.0 mm height with at least 2.0 gf/mm²within 30 seconds. The adjunct material can be able to compress withoutexcessive pressure to around 0.75 mm. The adjunct material should befully reabsorbed in about 120 days.

FIGS. 52A-52B show typical behavior of the adjunct material undercompressive and elongation forces, respectively. FIG. 52A shows theadjunct material 3000 with a compressive force applied thereto, whileFIG. 52B shows the adjunct material 3000 with an elongation forceapplied thereto. As shown, the adjunct material 3000 has sufficientintegrity and structure such that it is not compromised by theapplication of these forces. The amount of material and degree ofcompression to be applied can determine the mechanical properties of theresultant brick. Accordingly, one of skill in the art will understandthat the amount of material and degree of compression can be varied inorder to modify these properties.

With the above teachings, one skilled in the art will recognize thatadjunct 3000 may be comprised of one or more elastic core layers 3003 aswell as one or more flexible support layers 3001, 3002. The order andnumber of layers as well as their orientation result in multiplecombinations that are conceived within this disclosure. For example, theadjunct can include two external support layers connected by a single,central flexible layer. One skilled in the art will also appreciate thatthe adjunct 3000 can be formed of sandwiches of multiple flexiblesupport layers (e.g., three layers) with a number of (e.g., two) elasticcore layers.

Fibrous Adjunct Materials

In another embodiment, non-woven fibrous materials can form all orportions of an adjunct material. Like a woven adjunct material, themechanical properties of a fibrous adjunct material can be influenced bythe shape of the adjunct, the type of fibers used, and the density ofthe fibers.

The resulting material properties may also be influenced by processsteps used to create the adjunct. For example, FIG. 54A illustrates anadjunct material 3100 with a central region that is more dense thanregions adjacent the perimeter of the structure. FIG. 54D showspreprocessed adjunct material 3100D prior to a compressive processingstep that creates adjunct material 3100. Pre-processed adjunct material3100D is comprised of (woven or non-woven) fibers of a generallyhomogeneous structure and generally uniform density. By compressing thecentral region 3110 of 3100D to the flat height of adjunct material3100, a central region is created that is more dense than the perimeterregion.

FIG. 54B shows a wider structure 3100B being compressed to a more narrowstructure (by force or by shrinkage through heat) resulting in analigned fiber pattern with anisotropic material properties.

FIG. 54C shows a block 3100C that is pressed to increase the widthresulting in an anisotropic material with an aligned fiber patternperpendicular to that of the adjunct 3100B of FIG. 54B.

The construction of non-woven adjunct materials can be selected invarious ways, but can include a fleece (e.g., a material that is similarto the fine web of cotton or wool removed by the doffing knife from thecylinder of a carding machine) and/or melt blown fibers.

A non-woven adjunct material can be formed from various types of fibersthat are biocompatible and bioabsorbable. Examples of such materialsinclude various materials from which sutures are made, includingnaturally occurring fiber materials and synthetic fibers. Exemplarymaterials include polydioxanon (sold under the trademark PDS®),Polyglycerol sebacate (PGS), PGA (Polyglycolic acid and various formsthereof, marketed under the trademarks VICRYL® and/or NEOVEIL®), PCL(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(Polyhydroxyalkanoate), PGCL (Poliglecaprone 25, sold under thetrademark MONOCRYL®, PANACRYL® (Ethicon, Inc., Somerville, N.J.),polyglactin 910, polyglyconate, PGA/TMC (polyglocolide-trimethylenecarbonate sold under the trademark BIOSYN®), polyhydroxybutyrate (PHB),poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), absorbablepolyurethanes, regenerated cellulose, and oxidized regenerated cellulosefibers (ORC). Blends and/or copolymerizations of any of theaforementioned materials can be tailored to have a desired molecularweight, mechanical properties, and/or degredation rate.

One of skill in the art will understand that the fiber size of thenon-woven adjunct can be optimized in order to achieve desiredproperties. In a preferred embodiment, the fibers can be suture fibersfrom about 10-0 to 2-0 in size, i.e., about 0.02 mm to 0.3 mm. In a morepreferred embodiment, the fibers can be size 7-0, i.e., about 0.15 mm.

Adjuncts Having Mesh and Fibrous Layers

In other embodiments, the adjunct material can have other constructions,such as a woven or non-woven adjunct material surrounded by a mesh. Forexample, FIG. 55 shows a mesh 3200 formed from fibers 3201, can surroundadjunct material 3100. The mesh 3200 can have various configurations,and can include a plurality of fibers 3201 arranged in a repeatingpattern such as a honeycomb structure, as shown. The size of mesh, andtype of mesh can be varied, in addition to the construction of thenon-woven material described above, to modify the mechanical propertiesof the non-woven material as described above. A mesh can be positionedaround a core layer similar to the core layers previously described. Forexample, the mesh can surround a fleece core layer, or one made frommelt blown fibers. The mesh may be used to constrain adjunct material3100 in a desired state for use. Further, the mesh may be used tofacilitate attachment to a stapling device.

In general, the mesh can be a loosely woven mesh of fibers. The mesh canbe a mesh of fibers woven in a geometry that is transparent to light.The mesh can have a wide range of pore sizes, such as in the range ofabout 0.5 to 5 mm.

In general, the mesh material can be a mesh that is suitable forsurgical implantation. The mesh can be biocompatible and may bebioabsorbable. In one exemplary embodiment, the mesh can be PROCEED® orPHYSIOMESH®, both of which are manufactured by Ethicon, Inc. ofSomerville, N.J.

In certain aspects, the mesh surrounding the fleece material can becoated with a therapeutic agent such that the mesh can elute or releasethe therapeutic agent to a patient when the adjunct is positioned in apatient's body. The therapeutic agent may be a drug that promotes abeneficial outcome such as healing, or prevents infection.

Coating an Adjunct with a Therapeutic Substance

The fibers of an adjunct material can be coated with a therapeuticsubstance i.e., one that can aid in healing and/or combat or preventinfection and that can be effective to be released upon implantation ofan adjunct material. For example, FIG. 53A shows an adjunct material3013, loaded on the tissue facing surface 3058 of an anvil 3054 in whichthe adjunct material includes fibers 3010 coated with a therapeuticsubstance 3011 as shown in FIG. 53B. In another embodiment (not shown),the fibers in a woven adjunct material can be coated with a therapeuticsubstance. One skilled in the art will appreciate that thenumber/percentage of fibers coated with a therapeutic substance canvary. In another embodiment (not shown), only a small percentage of thefibers of the adjunct material are coated, e.g., in the range of about 5to 50% of the fibers by volume can be coated.

In some embodiments, the adjunct material may include one or moretherapeutic agents, such as, for example, drugs, clotting or sealingagents, antibacterial agent(s), and antimicrobial agent(s). It should beappreciated that any number of any suitable therapeutic substances canbe included on an adjunct material. The therapeutic agent can beconfigured to be released over time to aid the tissue in healing, forexample. In embodiments where more than one therapeutic agent isemployed, different therapeutic agents can be configured to release atdifferent rates.

Therapeutic substance coated onto the fibers can have variousproperties. Exemplary therapeutic substances that can be employed caninclude those that expedite binding as well as antibiotics, andantimicrobials. Exemplary therapeutic substances can include a mixtureof fibrinogen and thrombin. In one embodiment, fibrinogen and thrombincan be used as therapeutic substances for coating the VICRYL® suturewhich forms the adjunct material because lyophilized fibrinogen andthrombin (human or animal derived) are known to adhere to VICRYL® fiberswhen released from a fluid suspension VICRYL® fibers can be used in thetissue contacting surface. In another embodiment a small number ofVICRYL® fibers can be used. In another embodiment, VICRYL® fibers can bewoven (e.g., needle punch) into the structure of the adjunct material,e.g. at the core or on the support layers, and can be coated with atherapeutic substance. In certain aspects, when thrombin coated onto awoven adjunct, the thrombin can comprise about 1% or less of the wovenadjunct.

As previously mentioned, various antimicrobials can be coated onto thefibers of woven or non-woven adjunct material. Exemplary include, by wayof non-limiting example, triclosean and ionized silver. In anotherembodiment, antibiotics can be deposited only onto a woven layer of anadjunct material. Where a woven layer of an adjunct material includes anantibiotic, antimicrobial, or antibacterial woven therein or coated ontothe fibers, the antibiotic/antimicrobial/antibacterial can compriseabout 0.5% or less of the adjunct material.

A therapeutic substance can be coated on the fibers of the elastic corelayer of a woven adjunct material. When the therapeutic substance isdeposited on the fibers of the elastic core, the therapeutic substancecan be in liquid form and can be absorbed into the elastic core layer.This can allow the therapeutic substance to disperse into the tissuefollowing implantation of the adjunct material.

An adjunct material can include various other layers. In anotherembodiment, (not shown), the elastic core layer can have a film coupledto at least one side of the core layer. In an exemplary embodiment thefilm is made of PDS®. In another embodiment, the film can includePGA/PCL 75/250 polymeric fibers.

Modifying Region(s) of an Adjunct Material Based on Features of aSurgical Device

The adjunct material on the cartridge assembly can have variedproperties throughout or particular regions of the adjunct material canbe modified to correspond to a portion of the end effector to which theadjunct will be coupled. For example, when the adjunct material is to beused on a surgical stapler having a knife, e.g. surgical staplers 10,100, and 200, the properties of the adjunct can be modified in theregion in which the knife will cut through the adjunct material. Such amodification can include thinning out the flexible support layer, usingless material, the core layer only at this region, having a more looselywoven layer than other layers of the adjunct, or removing excessmaterial with a laser. In another embodiment, felting can be applied tospecified regions of the adjunct so that the knife can more easilypenetrate and cut through the adjunct material. In another embodiment,the properties of the adjunct can be modified by either adding orremoving fibers from the woven structure to make it stiffer or moreflexible, respectively. A zone of increased stiffness may be useful forattachment to the stapling device. In addition, zones of increasedflexibility may be help to promote optimal tissue interactions.

A felting process can be used to control dimensions and/or adjust alocal density of the adjunct material, such as to decrease a density ofa single layer or multiple layers of an adjunct material. Felting caninclude applying heat to a specific section of the adjunct material at atemperature between the material's glass transition temperature and itsmelting temperature. By applying heat above the glass transitiontemperature, and below the melting temperature the structure of thematerial can be altered. With this process it is possible to decreasethe density of the material while avoiding changes associated withcomplete melting of the material.

In an alternative embodiment, the adjunct material can be used on boththe anvil and cartridge side of a surgical stapler. For example, FIGS.56A and 56B demonstrate the use of adjunct material A on both the tissuefacing surface 3058 of the anvil portion 3054, and the cartridgeassembly 3060, wherein the staples 3070 are covered by the adjunctmaterial so that when deployed, the staples can pierce the adjunctmaterial. A thickness of the adjunct material thickness can be variedacross a lateral or longitudinal (not shown) length of the anvil and thecartridge assembly, such as by using methods described above. Such anasymmetric geometry on both tissue facing surfaces of the anvil andcartridge may be useful for tissue facing surfaces that are not flat,which may be useful when staples 3070 are of varying unformed height,formed heights, or both unformed and formed heights. In such anarrangement, it is important to note that the geometry of an adjunctmaterial on the first opposing jaw is not necessarily symmetric with thegeometry of an adjunct material on the second opposing jaw. In oneembodiment the combined thickness of both adjunct materials across alateral distance is approximately the same. In another embodiment, thecombined thickness of both adjunct materials across a lateral distanceis not the same.

Stapling Adjunct Material onto Tissue

The adjunct material described herein can be deployed onto tissue usinga surgical stapling device, e.g., surgical staplers 10, 100, 200, openlinear cutting stapler. In use, tissue can be engaged between acartridge assembly and an anvil of a surgical stapler at a surgicalsite, wherein at least one of the cartridge assembly and anvil has anadjunct material releasably retained thereon. The surgical stapler canbe actuated to eject staples from the cartridge assembly, through theadjunct material, and into the tissue. The adjunct material can help toreduce impact and trauma from the stapling, evenly distribute strainalong the staple line, and can compensate for variable tissue thicknessand allow staples secure onto thin or diseased areas of tissue.Different areas of the adjunct material can perform different functionswhen the adjunct material is stapled onto tissue.

FIG. 57A shows four adjunct materials that can be releasably coupled toan end effector of a surgical stapler. First and second adjunctmaterials can couple to a tissue facing surface 3058 of the anvil 3054and second and third adjunct materials can coupled to the cartridgeassembly 3060. Three regions of the adjunct material identified as B, C,and D, can each perform a different function. For example, the B regioncan be used for staple sealing, the D region can be used for stressrelief and collateral damage reduction, and the C region can be used forvariable thickness compensation. Accordingly, it can be possible toselect the adjunct material used in each region to meet desired surgicaloutcomes. When the adjunct material is deployed onto the tissue T andcoupled thereto via the staples S, the adjunct material can bepositioned along an outer surface of the tissue, as shown in FIG. 57B.The adjunct material can seal the staples, provide stress relief andreduce collateral damage to nearby tissue, and/or can compensate forvariable tissue thickness.

Crown-Side Staple-Specific Adjuncts

As mentioned above and shown in FIG. 58, punctures formed by staplesfired from a surgical stapler may result in the leakage of blood, air,or other fluids depending on the type of tissue being stapled. Moreparticularly, tissue can stretch in any of a variety of directions 4002,4004 after a staple 4006 is implanted therein, thereby stretchingpunctures 4008, 4010 formed by the staple legs. In some cases, bleedingor other leakage through staple punctures can be present even though astapled end of a vessel or other body lumen is successfully sealed.

One advantage of tissue adjuncts is their propensity to prevent orminimize leaks, such as fluid or gas leaks. Tissue adjuncts can performthis function by one or more of the following mechanisms: plugging holesor tears that occur at the staple puncture sites; restricting movementof tissue around staple puncture sites to prevent an increase in thesize of staple holes and/or to prevent tissue tears; and minimizingstrain gradients that occur between constrained tissues within thestaple line and free tissue adjacent to the staple line.

Embodiments of the devices and methods described herein can addressleakage from these punctures by providing one or more adjuncts that arecoupled to a staple and configured to plug or seal the punctures 4008,4010. As described above, the adjuncts can be formed from viscouscoatings (e.g., bio-absorbable urethane, etc.) disposed in staplecavities of a cartridge body containing staples. Upon ejection from thecartridge body, the adjunct coatings can become plugs that fillpunctures 4008, 4010 formed by the staple legs. The plugs can becompressed when the staples are formed through tissue, and as theadjunct material is compressed it can expand and fill any defects in thetissue that could create leak paths. The adjunct plugs can also serve todistribute pressure applied by the staple, thereby reducing thepossibility of a staple pulling through the tissue and failing to fastenthe tissue as intended (so-called “cheese wiring”). Still further, aviscous coating used as an adjunct material can also include otherhealing properties, as described above (e.g., antimicrobial properties,hemostats, etc.) or other features to help with the formation of staples(e.g., lubricants, etc.).

FIG. 59A illustrates one embodiment of adjuncts 4012 disposed about legsof a surgical staple 4014. The illustrated adjuncts 4012 are in the formof plugs disposed about each leg of the staple, that is, they have atapered cylindrical shape configured to wedge into a puncture created bya staple leg as it passes through tissue. The adjuncts 4012 can beformed at any point along the legs of the staple 4014 and, in someembodiments, can be configured to slide along the legs, as described inmore detail below.

In the embodiment shown in FIG. 59B, adjuncts 4016 can be positioned ata junction between a crown 4018 of the staple 4014 and each staple leg4020, 4022. The adjuncts 4016 can again have a shape that tapers fromthe crown 4018 toward a distal end of the staple legs 4020, 4022 suchthat the adjunct forms a plug configured to be received within apuncture in tissue. The adjuncts 4016 can further be formed from aflowable material, e.g., a hydrogel, which can retain its shape prior toimplantation but can become more flowable upon implantation in tissue tofill a puncture or other defect in the tissue. In other embodiments, aswellable material can be employed, i.e., a material that increases involume upon contact with water or other bodily fluid.

FIG. 60 illustrates an alternative embodiment of adjuncts 4024 disposedaround legs of staple 4026. In this embodiment, the staple 4026 ishoused within a staple cavity of a surgical stapler's cartridge body4028. Adjunct plugs 4024 are disposed around each leg of the staple 4026at a distal end thereof. In some embodiments, the adjuncts 4024 can beseated in small cut-outs or shelves formed in the cartridge body 4028(compare to FIG. 62). The adjuncts 4024 can be configured to slide overthe legs of staple 4026, as shown in FIG. 61.

In use, as shown in FIG. 62, tissue 4030 can be clamped between thecartridge body 4028 and an anvil 4032 and the staple 4026 can be ejectedout of the cartridge body through the tissue and into the anvil. Theadjuncts 4024 can abut against the tissue 4030 and begin to slide overthe legs of the staple 4026 as it is ejected from the cartridge body(see FIG. 61). Ultimately the adjuncts 4024 can end up compressedbetween the tissue 4030 and a crown of the staple 4018. Because theadjuncts 4024 can be formed from a material that becomes flowable uponcontact with water or other bodily fluid, or under compressive forces,the cylindrically-shaped adjuncts 4024 shown in FIG. 61 can flow intothe punctures in the tissue 4030, as shown in FIG. 62.

Viscous coatings and other flowable or swellable materials can besuitable choices for an adjunct material because they can adapt tovarying forces experienced by tissue at different locations within thebody. FIGS. 63A and 63B illustrate that such adjunct materials can beused to effectively seal staple leg punctures that expand inward towardone another, as can be the case when the tissue is under compression, aswell as staple leg punctures that expand outward away from one another,as can be the case when the tissue is under tension. By way of example,tissue under tension can often be found in the thoracic cavity, e.g.,lung tissue and/or cardiovascular tissue (FIG. 63B), while tissue undercompression can often be found outside of the thoracic cavity (FIG.63A).

FIGS. 64A and 64B provide alternative views of the configuration shownin FIG. 63B. Tissue 4034 that is under tension can cause staple legpunctures to expand outward from the staple 4036. Accordingly, flowableadjunct plugs 4038 in the form of gel plugs disposed around each leg ofthe staple 4036 can be pushed outward by compression between the crownof the staple and the tissue 4034 into the punctures. The gel can sealthe expanded punctures, thereby preventing any leakage therethrough.

As noted above, FIGS. 59A-64B show adjunct material disposed around legsof a surgical staple or formed at an inner junction between a crown ofthe staple and the staple legs. In an alternative embodiment shown inFIG. 65, adjunct material 4040 can be coupled to an outer surface of thestaple 4042 at the junction between a crown 4044 of the staple and eachstaple leg 4046, 4048. The adjunct material 4040 can be a flowable orswellable material in some embodiments, such as a hydrogel. Such amaterial can expand outward upon contact with tissue and fill thepunctures formed by the staple legs 4046, 4048. The adjunct material4040 in FIG. 65 is in the shape of a cylindrical plug, however any of avariety of other shapes are also possible. As mentioned above, otherpossible shapes can include taper along a leg of the staple, or entirelydifferent shapes can be utilized, such as a cube, hexagonal extrusion,etc.

A shape of the staple 4042 can be modified to accommodate the adjunctmaterial 4040, as shown in FIG. 66. In some embodiments, for example,right-angle corners of the staple 4014 shown in FIGS. 59A and 59B can bechamfered to provide attachment surfaces for the adjunct material 4040.The crown 4044 of the staple 4042 also has a broader, flat shape, asopposed to the cylindrical rod or square cross-sectional shape of thestaple 4014 in FIG. 59. In addition, both the staple 4042 and theadjunct material 4040 can have any of a variety of sizes. FIGS. 67A-67Cillustrate embodiments of staples 4050, 4052, and 4054 that have a samewidth and leg length, but accommodate increasing amounts of adjunctmaterial 4056, 4058, 4060.

FIGS. 68A-68C illustrate the implantation of the staple 4042 shown inFIG. 65 in a patient's lung. The staple 4042 can be initially storedwithin a staple cavity of a surgical stapler cartridge body 4062. Oncetissue 4064 is disposed between the cartridge body 4062 and an anvil4066, the staple 4042 can be ejected from the staple cavity through thetissue and into the anvil. Upon contact with the lung tissue 4064, thehydrogel adjunct material 4040 can expand to fill any gaps or defectssurrounding the punctures formed by the staple legs 4046, 4048.

The flattened-crown staple of FIG. 65 is just one embodiment of a staplethat can accommodate attachment of adjunct material thereto. FIGS. 69Aand 69B illustrate still other alternative staple geometries that canhave adjunct material coupled thereto, e.g., disposed about a legthereof, or coupled to an outer or inner surface of a crown. U.S. patentapplication Ser. No. 14/138,516, filed on Dec. 23, 2013, the entirety ofwhich is incorporated herein by reference, discloses still furtherstaple geometries that can be combined with the adjunct materialsdisclosed herein. Regardless of the particular staple geometry orattachment mechanism for an adjunct material, the adjunct material canbe configured to fill and seal individual punctures formed by the staplelegs.

FIG. 70 illustrates an alternative embodiment of an adjunct in the formof a pledget 4066 that is configured to seal around both a first leg anda second leg of a surgical staple 4068. The pledget 4066 is shownpressed against a crown (not shown) of the staple 4068 and can be formedfrom a flowable and/or swellable material, such as a hydrogel or othergel, as discussed above. The gel can be configured to retain its shapewhen disposed within a surgical stapler cartridge body, as shown in FIG.71A, but to become more flowable in all directions upon contact withtissue, water, or other fluid, as shown in FIG. 71B.

FIGS. 72A and 72B show the surgical staple 4068 and adjunct pledget 4066from a side view before and after implantation. As shown in FIG. 72B,the pledget 4066 has expanded outward and flowed into tissue 4070 uponcontact therewith. The gel material of the pledget 4066 can thereby sealthe punctures formed by the staple 4068, as well as distribute pressureapplied to the tissue by the a crown 4072 of the staple 4068.

In still other embodiments, adjunct material can be in the form of acoating disposed over all or a portion of a surgical staple, as shown inFIGS. 73 and 74. In particular, staple 4074 of FIG. 73 includes acoating 4076 of an adjunct material disposed over an entire outersurface thereof. The adjunct material employed in the coating 4076 canbe configured to swell upon contact with tissue or bodily fluid, suchthat once the staple 4074 is implanted in tissue the coating will expandaway from the staple and fill any gaps that may be present. FIG. 74illustrates a side cross-sectional view of tissue 4078 having multiplerows of staples 4074 disposed therein. The staples 4074 can seal thetissue 4078 together at the center of the figure, such that fluid cannotpass and the tissue could be transected between the staples 4074.

Other non-flowable materials can also be employed as adjuncts in someembodiments. For example, a compressible foam can be used as an adjunctmaterial in combination with a gel or other flowable material, or on itsown. FIG. 75 illustrates one embodiment of a staple 4080 having a foamadjunct 4082 disposed around both legs of the staple. Attempts toutilize foam in combination with staples may sometimes encounter aproblem wherein the foam rotates about a crown of the staple duringimplantation. The staple 4080 addresses this problem, and minimizes thispossibility, by incorporating an additional pledget 4084 between a crownof the staple and the foam adjunct 4082. The pledget 4084 can providesupport to the foam adjunct 4082 during implantation to prevent it fromrotating about the crown of the staple. The pledget 4084 can be formedfrom a rigid biocompatible material, or can be formed from a flowablematerial as described above. In the latter embodiment, a gel or otherflowable material can retain its shape prior to implantation so as toprovide the necessary support for the foam adjunct 4082, andsubsequently flow into defects in tissue after implantation. U.S. Pat.Pub. No. 2011/0192882 to Hess et al., the entirety of which isincorporated herein by reference, discloses additional techniques forcoupling staples to rigid pledgets and incorporating them into acartridge body that can be combined with the adjunct materials disclosedherein.

In some embodiments, it can be desirable to prevent any adjunct materialfrom coming into contact with the cartridge body of the surgical staplerduring implantation of a staple. If there is contact between thecartridge body and adjuncts, it is possible that the adjunct materialcan be scraped off the staple as it is ejected from the cartridge body.In embodiments where the adjunct material is a hydrogel or otherflowable and/or swellable material, it is further possible that theadjunct material could interfere with ejection of a staple if it was,for example, scraped off into a staple cavity and left to expand thereor flow into neighboring portions of the surgical stapler. Accordingly,in certain embodiments sealing adjuncts disposed within a staple cavityof a surgical stapler cartridge body can be configured to be ejectedtherefrom along with a staple without contacting the cartridge body.

There are a number of ways to ensure that the adjuncts do not contactthe cartridge body. In one embodiment, adjunct material can be coupledto a staple such that the staple shields the adjunct from contact withthe cartridge body during ejection. The staple shown in FIG. 65 is oneexample of a staple that shields adjunct material from contact with thecartridge body because the adjunct material is essentially behind thestaple as it is ejected from the cartridge body. In other embodiments,adjunct material can be tucked into an area extending between the legsof a staple, such as in the staple shown in FIG. 59B. This configurationcan also shield the adjunct material from contacting the cartridge bodyduring ejection from a staple cavity.

In other embodiments, the staple cavity openings in the cartridge bodycan be shaped to accommodate passage of at least one sealing adjunctcoupled to a surgical staple. FIG. 76 illustrates one embodiment of acartridge body 4086 that includes a plurality of staple cavities 4088having openings shaped to accommodate the staple 4080 and foam adjunct4082 shown in FIG. 75.

FIG. 77 illustrates an alternative embodiment of a cartridge body 4090having a plurality of staple cavities 4092 shaped to accommodate astaple 4094 having a plurality of adjuncts 4096 coupled to an outerportion of each staple leg. FIGS. 78A-78C illustrate various embodimentsof staple cavity openings that are configured to allow for passage ofone or more adjuncts coupled to a surgical staple. In the top view ofFIG. 78A, for example, a deck 4098 of the cartridge body is shown havingan opening 4100 formed therein. The opening 4100 can include cut-outs4102, 4104 formed at opposite ends thereof that are sized to accommodatesealing adjuncts 4106, 4108 that are coupled to a flat form staple 4110that is similar to the staple shown in FIG. 65. In the alternativeembodiments of FIGS. 78B and 78C, additional cut-outs are providedsurrounding the legs of the staple 4110 to accommodate differentconfigurations of adjunct material coupled thereto.

Anvil-Side Segmented Adjuncts

Certain embodiments of the methods and devices described herein includeone or more adjunct segments disposed on an anvil-side of a surgicalstapler, that is to say on an opposite side of staple tissue from thecrown-side adjuncts described above. These anvil-side adjuncts can beused in addition to the crown-side adjuncts. While the crown-sideadjuncts serve to prevent leakage caused by tissue deformation aroundthe staple legs, the anvil-side adjuncts described below can preventtissue damage from strain caused by the staple and the staple-line as awhole.

Adjunct segments disposed on the anvil-side of a surgical stapler caninclude sheets of biocompatible or bioresorbable material, discreteadjunct segments each designed to interact with legs of an individualstaple, discrete adjunct segments each designed to interact with legs ofmultiple staples, discrete adjunct segments attached to each other, orany suitable combination thereof. In some embodiments, each adjunct canbe of a size that when placed adjacent the anvil-side of a surgicalstapler, each adjunct spans only a single staple-forming opening.Further, in some embodiments, each adjunct can be of a size that whenplaced adjacent the anvil-side of a surgical stapler, each adjunct spansmultiple single staple-forming openings.

In addition to preventing damage from the staple in the stapled tissue,adjunct segments disposed on the anvil-side of a surgical stapler canserve to hold together staples that do not interact with tissue during astapling procedure, that is to say excess staples. For example, inembodiments where the anvil-side adjuncts include sheets of material,adjunct segments that are each designed to interact with the legs ofmultiple staples, or adjunct segments that are attached to each other, asurgical stapler can be fitted across a segment of tissue, such as aportion of intestinal tissue or a vessel, whose diameter is shorter thanthe length of the staple line created by the surgical stapler. In thatcase, there will be staples that do not pass through tissue. Removal ofthose excess staples that are not securing tissue from the patient isfacilitated if they remain attached to the tissue through the adjunctsegments. The surgeon or stapler operator can then sever select adjunctsto detach the excess staples and he or she can remove all of the excessstaples while minimizing the potential for loss of an excess stapleinside the patient.

Though, as described in more detail below, some embodiments of thesegmented adjuncts described herein can be used on a cartridge, adjunctsegments can be deposited to the anvil-side of the surgical stapler inthe staple shaping depressions in the anvil-side of the surgical stapleras a liquid that hardens over time or after exposure to curingradiation. Adjuncts can also be supplied as discrete adjuncts attachedto a sheet. The sheet can be a connective film, such as continuous film.The sheet can be a woven mesh. In some embodiments, a plurality ofdiscrete adjuncts can be connected through a plurality of connectingbranches, through a plurality of threads, or other suitable means forconnecting the adjuncts with biocompatible or bioresorbable materialthat does not impede the functioning of the staples or irritate thetissue once the staples are applied. When the adjuncts used areconnected through a plurality of connecting branches, the surgicalstapler can include one or more features to sever the connectingbranches as the staples are deployed into tissue.

FIG. 79 shows a top view of one embodiment of a plurality of adjunctsegments coupled to one another 4112, such as might be seated in acartridge for use with a surgical stapler or seated directly in asurgical stapler. The individual adjunct segments 4114 are shown to spana plurality of staple forming openings 4116, and when applied to tissue,as seen in the top portion of the figure on the right, there can beexcess adjunct segments that do not attach to tissue 4120. Theindividual adjunct segments 4114 are joined together through branches4118. The branches 4118 can be made of a similar material as theadjuncts, but made thinner than the adjuncts and of a diameter thatallows for the branches 4118 to be broken 4122 by the application offorce. In this way, excess adjunct segments 4120 can be removed.

FIG. 80 shows a perspective view of an alternative embodiment of aplurality of adjunct segments 4124 applied on the anvil-side of asurgical stapler. The plurality of adjunct segments 4124 shown are heldtogether by connecting threads of filaments 4126 between individualadjunct segments 4128. Each adjunct segment 4128 is configured to span aplurality of staple forming openings 4132.

A film that may include a woven material 4130 can overlay the individualsegmented adjuncts 4128. The film, optionally including a woven material4130, can help to mitigate the damage to stapled tissue by distributingforces.

FIG. 81A shows a view of one embodiment of surgical end effector 4134having a plurality of adjunct segments 4124. The surgical end effector4134 is shown accepting a vessel 4136. In FIG. 81B, the surgical endeffector 4134 is shown transecting the vessel 4136, causing staples toengage with the adjunct segments 4124 of FIG. 81A. FIG. 81C shows thevessel 4136 and adjuncts 4124 after transection of the vessel 4136.Filaments or threads 4126 can connect the adjuncts 4124, and thefilaments or threads 4126 can aid in the application of the plurality ofadjuncts 4124 to the surgical end effector 4134. Yet the filaments orthreads 4126 can be torn when separating the ends of the transectedvessel 4136. The filaments or threads 4126 can hold excess adjunctsegments 4138 in place until removed by a surgeon.

FIG. 82 shows another embodiment of segmented adjuncts 4140 disposed onthe anvil-side of a surgical stapler 4142. Each individual adjunctsegment 4144, 4146 spans multiple staple forming openings. As shown,each adjunct segment 4144, 4146 can have a distinct configuration fromthat of the adjunct segments adjacent to it. However, each adjunctsegment 4144, 4146 interlocks with its neighbors. In this way, it may bepossible to have some degree of adhesion between adjacent adjunctsegments 4144, 4146 so that no filaments or branches are needed, and sothat no filaments or partial branches will be exposed after the excessadjunct segments are removed from stapled tissue. Additionally, theadjuncts are shown as including a woven material.

FIG. 83 shows a portion of a surgical staple anvil 4148 with a pluralityof staple forming openings filled with a viscous sealant material 4150.Some of the ways in which the material arrives in the staple formingopenings of the staple anvil 4148 are shown in FIGS. 84-86D. FIG. 84shows a surgical stapler anvil 4152 with staple forming openings inwhich pre-formed sealing gel 4154 is placed, as described in greaterdetail below. FIG. 85 is a cross sectional view of an anvil 4156 withstaple forming openings filled with a sealing liquid or gel 4158. Thesealing liquid or gel 4158 has a film or layer 4160, above the bulk ofthe sealing material, that is flush with the surface of the anvil 4156.FIG. 86A shows the addition of the sealing material 4158 in a liquid orgel state to staple forming openings on an anvil 4156. FIG. 86B showsthe staple forming openings filled with sealing liquid or gel, and FIG.86C shows the creation of the film or layer 4160. A light source, suchas a UV light source, provides lights at an energy level sufficient tocause partial curing of the sealing material 4158 to form the film orlayer 4160.

In some embodiments, the staple forming openings of an anvil can containcompletely cured sealing material 4162, as shown in FIG. 86D. Fullycured sealing material 4162 can have different materials properties thanthe partially cured material shown in FIG. 85A. FIG. 87 shows a staple4164 that was shaped using a surgical stapler with partially curedsealing material in the staple forming openings of the stapler anvil.The staple 4164 has legs that pass through the cured layer 4160, intothe uncured sealing material 4158, and back through the cured layer4160, and in some embodiments, the end of each leg of the staple 4164can end in tissue. The sealing material helps to prevent any passage offluids through tissue, adjacent to the staple, as well as preventingundesirable deformation or damage to the tissue.

FIG. 88 shows an alternate way of delivering adjuncts for the anvil-sideof surgical staples 4166 that includes multiple adjuncts 4168 that fitinto staple forming openings on the anvil of a surgical stapler and athin connecting film 4170. The thin connecting film 4170 can be acontinuous film that allows for easy transport and placement of multipleadjuncts 4168 at once.

FIG. 89 is a perspective view of showing adjuncts 4172 with 4174 meshmaterial. FIG. 90 shows an exploded view of the view of FIG. 89. FIGS.91A and 91B show adjuncts 4184 that are cured with a film above theadjuncts 4186, in which the film connects the adjuncts 4186, as well asdiscrete adjuncts which are not connected 4190 to each other. In thesystem of discrete adjuncts 4188, each adjunct 4190 has un-cured sealmaterial that fits the within the staple forming openings of the anvilof a surgical stapler. Each adjunct also has a layer of cured material4194 above the uncured sealing material 4192.

FIG. 92 shows a cross-sectional view of a surgical staple 4198 in acartridge 4196 that is opposite the anvil 4202 of a surgical stapler. Inthe figure, tissue 4200 is between the cartridge 4196 and the anvil4202. The anvil 4202 is shown to have multiple staple forming openings4190, each opening filled with uncured sealing material 4192 and havinga layer of cured sealing material 4194 over each staple forming opening4190.

FIG. 93 is a cross-section view of a surgical staple 4198 inserted intissue 4200 with an adjunct that includes both cured and uncured sealingmaterial present on the free-ends of the legs of the staple. The legs ofthe staple have passed through the tissue, through a cured portion ofthe adjunct material 4204, through a portion of un-cured adjunctmaterial 4206 and then back into the tissue 4200. FIG. 94 shows curingof the un-cured adjunct material 4206 in FIG. 93 so that it becomes acured, conforming material 4210. A light source 4208 provides theappropriate radiation to cure the liquid or gel setting material 4206after the material has spread to conform to the surface of the tissue4200.

FIG. 95 shows a grouping 4212 of discrete adjunct segments 4214 that arejoined by a plurality of connecting branches of adjunct material 4216.The adjunct segments 4214 in the grouping 4212 can be partially or fullycured, such that the grouping 4212 can be stored for long periods oftime. FIG. 96 shows the adjunct grouping 4212 of FIG. 95 fitting overstaple forming openings, or anvil pockets, 4220 on a surgical stapleranvil 4218.

FIG. 97 shows an anvil 4222 with adjunct-separating features 4226between the staple forming openings 4224. FIG. 98 shows a side view ofan embodiment of a surgical stapler that includes a staple 4228 in astaple cartridge 4230 and a plurality of adjunct segments 4214 coupledto the anvil 4222. The plurality of adjunct segments 4214 are joined bybranches 4216. The branches 4216 are severed by the sharp features 4216when the staple 4228 is inserted into the tissue (4232 in FIG. 99). FIG.99 shows the staple 4228 as it is formed by actuation of the surgicalstaple, ad FIG. 100 show the staple 4228 after it is fully implanted inthe tissue 4232, with the branches 4216 severed, making breaks 4234 inthe branches, and with the adjunct segments 4214 between a portion ofthe ends of the legs of the staple 4228 and the tissue 4232.

FIG. 101 is a cross-sectional view of an embodiment of a retainer 4238to hold adjunct material 4240 in place against a surgical stapler anvil4236. FIG. 102A is a cross-sectional view of the retainer 4238 and anvil4236 shown in FIG. 101, with adjunct material 4240 between the anvil andthe retainer. FIG. 102B is a variation of the embodiment shown in FIG.102A in which the adjunct material is present only as discrete adjuncts4240, without any connecting material.

FIG. 103 is a cross-sectional view of an embodiment of a staple formingopening 4246 with bulge tabs 4244. The tabs 4244 are shaped duringmanufacturing into retainer features. FIG. 104 shows the staple formingopening 4246 of FIG. 103 filled with a plug element 4250, or adjunctmaterial, and the bulge tabs 4244 shaped into trapping features 4248.FIG. 105 is a top view of the staple forming opening 4246 shown in FIG.103. The line A-A is that along which the cross-sectional views aretaken.

FIG. 106 shows a perspective view of one embodiment of a surgicalstapler with adjunct segments 4256, 4258 associated with both the anvil4254 and staple cartridge 4252. In this embodiment, the adjunct segments4258 on the anvil 4254 have branches of adjunct material or filaments4260 between the adjunct segments 4258. The adjunct segments 4256 on thestaple cartridge 4252 interlock with each other, such that a notch 4262in one adjunct segment receives a protrusion 4264 from its neighboringadjunct segment. In this way, additional means of holding together theadjuncts 4256 on the staple cartridge 4252, which is on the crown-sideof the staples, are needed. Further, the adjuncts 4256 on the staplecartridge 4252 span more than one staple, so that two or more stapleswill be connected by each adjunct.

FIGS. 107 and 108 show an embodiment of a surgical stapler with an anvil4266 that includes attachment 4272 and alignment features 4274 foradjunct material 4270. FIG. 107 is an exploded view of the anvil 4266with staple forming openings 4268 and features 4274 on the side of theanvil for anchoring or interfacing with loops 4272 on a sheet of adjunctmaterial 4270. FIG. 108 shows the adjunct material 4270 flush againstthe anvil 4266 with the loops 4272 attached to the features 4274 whichare shown to be tabs or pegs that attach to the loops. Such features4274 can be present on a staple cartridge and used with a similar typeof adjunct material instead of or in addition to being used on the anvil4266 of a surgical stapler.

FIGS. 109-111 show an embodiment of a surgical stapler 4276 with adjunctassemblies 4284, 4278 coupled to both the anvil 4282 and the staplecartridge 4280 of the stapler. The adjunct assemblies 4284, 4278 areshown to include adjunct segments 4286, 4288 that are joined by a sheetof adjunct material. On the anvil 4282, there are a plurality of stapleforming openings 4290 which can accept adjunct segments 4286. FIG. 111shows the relative thickness of an adjunct segment 4286 to that of thesheet of adjunct material. The adjunct segments 4286 on the stapleranvil 4282 can include partially cured or fully cured sealing material,as described above. The adjunct material 4278 for use with the staplecartridge 4280 has adjunct segments 4288 which can fit over the ends ofthe staples in the cartridge 4280, either in contact with or above thestaple legs. In practice, using such a surgical stapler 4276 wouldinsert staples into tissue in with adjunct material both at the crown ofeach staple and at the anvil-side of each staple, thus potentiallyreducing leaking and tissue damage caused by the staple.

FIG. 112 shows a cross-sectional view of one embodiment of a pluralityof adjunct segments 4288 (e.g., micro-fingers) connected to one anotherby a film 4278. These adjunct segments 4288 may not correspond toindividual features on a stapler anvil or a staple cartridge, butinstead may serve to act as a cushion or a light-weight, highlyconformable and compressible material. FIGS. 113A and 113B showcross-sectional views of a surgical stapler, similar to that shown inFIG. 109, with a staple 4294 in a cartridge 4292 with an adjunctmaterial 4296 that includes a plurality of adjunct segments 4292 thatcan act as a light-weight, conformable and compressible material 4296.The anvil 4300 shown in FIG. 113A has staple forming openings 4302 inwhich include adjunct segments 4304 that are attached to a sheet ofadjunct material 4306. FIG. 113B shows the staple 4294 after the staplerhas been actuated on tissue 4308. The tissue 4308 contacts adjunctmaterial with micro-fingers 4298 near the crown of the staple andthicker, continuous adjunct material 4304 at the anvil-side of thestaple.

FIGS. 114A and 114B show an embodiment of a surgical stapler component4310 that includes adjunct segments of varying thickness 4312. Eachadjunct segment is discrete and spans only one staple. FIG. 114B showsthat adjunct segments of greater thickness 4318 are located nearest thecenterline of the stapler component 4310, and that the thinner adjunctsegments 4316 correspond to staples further away from the centerline,where a cut in stapled tissue would be made.

FIG. 115 shows another embodiment of adjunct segments 4322, 4326 on onepart of a surgical stapler. The adjunct segments 4322, 4324 are not ofuniform thickness. Each adjunct segment has a thick side, 4328, 4330,and a thin side 4332, 4334. Each adjunct segment 4322, 4324 spans morethan one staple 4326 location shown in the exemplary staple cartridge4320. The adjunct segments are shown with their thick sides 4328, 4330towards the center of the staple cartridge 4320. When the surgicalstapler cuts through tissue after stapling the tissue, it will cut thetissue through the center of the cartridge, between the thick sides4328, 4330 of the adjunct segments. In this way, the adjunct segments4322, 4324 provide more support to the staples nearest the free ends ofthe tissue.

FIG. 116 shows a cross-sectional view of the stapler of FIG. 115. Thestaple cartridge 4320 holds staples 4336. Over the staples 4336 areadjunct segments 4334 and 4324 which have their thick sides 4330, 4328near the center of the cartridge and their thin sides 4324, 4322 towardthe outer edges of the cartridge 4320, over the outermost staples. Thestapler anvil 4338 has staple forming openings 4340, over which areadjunct segments 4342, 4344. The anvil-side adjunct segments 4342, 4344,are shown to have their thick sides 4346, 4348 near the venter of theanvil, corresponding to the innermost staples. The thin sides 4350, 4352of the anvil-side adjuncts 4342, 4344 are located toward the edges ofthe anvil such that the thin sides are associated with the outermoststaples once the stapler is actuated.

FIG. 117 shows an embodiment of a surgical stapler component 4310 thatincludes adjunct segments of varying thickness 4312. Each adjunctsegment is discrete and spans only one staple. Adjunct segments ofgreater thickness 4318 are located nearest the centerline of the staplercomponent 4310, and that the thinner adjunct segments 4316 correspond tostaples further away from the centerline, where a cut in stapled tissuewould be made. These adjunct segments are discrete, not interlocking asthose shown in FIG. 115.

FIGS. 6118A and 118B show a multi-material adjunct 4354 that includes afilm 4356 with openings 4360 and a base layer 4358 with connectingfeatures 4362. The base layer 4358 can be a layer of elastomericmaterial. The connecting features 4362 can be shaped to fit through theopenings 4360, for example the connecting features 4362 shown arecolumns and the openings 4360 are circular holes. The connectingfeatures 4362 and openings 4360 can be any suitable shape, symmetricalor asymmetrical, as in when a particular orientation between the baselayer 4358 and the film 4356 is desired. FIGS. 119A and 119B show theadjunct of FIGS. 118A and 118B in context, with a staple 4364 shown.FIG. 119A shows the staple prior to insertion into the adjunct 4354. Thestaple 4364 is shown as aligned with the connecting features 4362 sothat each leg of the staple moves through a connecting feature 4362 whenstapling tissue. FIG. 119B shows the staple 4364 after being movedtoward an anvil of a surgical stapler.

FIGS. 120-122 show different embodiments of a surgical staple andadjunct in tissue, with the legs of the surgical staple shaped to retainthe tissue in a particular configuration. FIG. 120 shows a staple 4368in tissue 4370 with adjunct material 4372 near the anvil-side of thestaple, such that the adjunct material 4372 acts as a seal to avoidleaking from the tissue 4368. FIG. 121 shows a staple 4374 in tissue4376 with an adjunct on the anvil-side of the staple 4374. The adjunctincludes a film 4378, a depression in the film 4382, and a thicker areain the adjunct 4380 into which the ends of the legs of the staple 4374move when the staple forms. In FIG. 122, the staple 4374 is used with anadjunct with a film 4378, multiple depressions in the film per staple4386, and a pair of thicker areas in the adjunct 4380 into which theends of the legs of the staple 4374 move when the staple forms, one pairof thicker areas per staple.

FIGS. 123A-123E show different embodiments for a plurality of adjunctscoupled to a surgical stapler anvil. The adjunct array 4388 shown inFIG. 123A includes portions near the anvil edge 4392, portions near theanvil centerline 4390, and multiple adjunct segments 4394. The adjunctsegments shown include openings 4400 for staple legs to pass through asthey move toward the anvil and openings 4402 for staple legs to passthrough as they move away from the anvil during staple forming. Theadjunct segments 4394 connect to each other and to the portions of theadjunct array near the anvil edge 4392 and anvil centerline 4390 throughbranches of adjunct material 4398. The edge 4392 and centerline 4390portions also have branches 4396 to connect to the adjunct segments4394. FIG. 123B shows an adjunct assembly 4404 that is similar to thatshown in FIG. 123A. The adjunct array 4404 shown in FIG. 123B includesportions near the anvil edge 4392, portions near the anvil centerline4390, and multiple adjunct segments 4408. The adjunct segments showninclude openings 4412 for staple legs to pass through as they movetoward the anvil and openings 4414 for staple legs to pass through asthey move away from the anvil during staple forming. The adjunctsegments 4408 connect to each other and to the portions of the adjunctarray near the anvil edge 4392 and anvil centerline 4390 throughbranches of adjunct material 4406. Unlike the adjunct array 4388 in FIG.123A, the adjunct array 4404 has no connectors between rows of adjunctsegments. The adjunct array 4416 of FIG. 123C is similar to that of FIG.123B, in that there are no connectors between the rows of adjunctsegments, only connectors 4420 between each adjunct segment 4418 and itsneighboring segment. Each segment has openings 4422 for staple legs topass through as they move toward the anvil and openings 4424 for staplelegs to pass through as they move away from the anvil during stapleforming. The adjunct array 4426 shown in FIG. 123D includes portionsnear the anvil edge 4428, portions near the anvil centerline 4430, andmultiple adjunct segments 4432. The adjunct segments shown includeopenings 4438 for staple legs to pass through as they move toward theanvil and openings 4440 for staple legs to pass through as they moveaway from the anvil during staple forming. The adjunct segments 4432connect to each other and to the portions of the adjunct array near theanvil edge 4428 and anvil centerline 4430 through branches of adjunctmaterial 4434, 4436. The adjunct array 4442 shown in FIG. 123E isdifferent from that shown in FIG. 123D and includes portions near theanvil edge 4444, portions near the anvil centerline 4446, and multipleadjunct segments 4452. The adjunct segments shown include openings 4458for staple legs to pass through as they move toward the anvil andopenings 4456 for staple legs to pass through as they move away from theanvil during staple forming. The adjunct segments 4452 connect to eachother and to the portions of the adjunct array near the anvil edge 4444and anvil centerline 4446 through branches of adjunct material 4448,4454, 4450.

FIG. 124 shows a first side 4460 and a second side 4470 of a pluralityof adjuncts 4464 that are connected in a row. The first side view 4460show the adjunct segments 4464, their connectors 4462, the openings 4466in the adjunct segments for when the legs move towards the stapler anvilduring staple forming, and the openings 4468 in the adjunct segments forwhen the legs move away from the stapler anvil during staple forming.The second side view 4470 shows elements of the first side view 4460,but there is additional material on this side of the adjuncts 4464.Through this additional material, there are openings 4474 in the adjunctsegments for when the legs move towards the stapler anvil during stapleforming, and the openings 4472 in the adjunct segments for when the legsmove away from the stapler anvil during staple forming.

FIGS. 125-129 show embodiments of adjuncts segments that overlap andinterlock to some degree when in use with surgical staples. Theconfigurations shown can be used to accommodate for movement in thetissue, such as expansion on contraction after stapling. In FIG. 125,there are two configurations of adjunct segments, 4512, 4514. Theadjunct segments shown 4512, 4514 are minor images of each other. Eachadjunct segment spans two staples. For example, as in FIG. 127, eachadjunct segment is shown with two staple crowns in contact with eachsegment. However, it should be noted that in the configuration shown inFIGS. 126 and 127 each staple, aside from the staples at the end of therow, contacts two overlapping adjunct segments. In FIG. 126, the twoadjunct segments 4512 and 4514 are seen in an extended configuration4526 and in a compact configuration 4528. Openings are shown in theadjunct segments through which staple legs pass as staples are formed bymoving from the staple cartridge toward the anvil in a surgical stapler.As can be seen, when the adjunct 4512, 4514 are overlaid, some of theopenings overlap and align to allow a staple leg to pass through.Opening 4516 aligns with opening 4522, and opening 4520 aligns withopening 4518 at the bottoms of the adjunct segments. Opening 4518 isshown as not aligning with any other opening, but opening 4518 may alignwith opening 4525 of another adjunct segment that is similar to 4512.Similarly, opening 4524 is not shown aligning with any other opening,but it may align with opening 4516 of another adjunct segment that issimilar to 4512. FIG. 126 shows that in an extended configuration 4526,adjacent openings on the top portions of the adjunct segments, 4525 and4524, are further apart than in a compact configuration 4528. FIG. 128shows the relative position of two adjacent adjunct segments that aresimilarly oriented 4514. In an extended configuration 4526 there is agap or space between the adjunct segments 4514. In a compactconfiguration 4528 the adjacent adjunct segments 4514 are very close, insome instance touching, and in some instances slightly overlapping. FIG.129 shows a compact configuration 4528 in which only half of the adjunctsegments are visible, such as when the adjunct segments are opaque andonly the topmost adjunct segments are visible.

FIGS. 130A-130C show embodiments of adjunct segments that connectadjacent surgical staples. FIG. 130A shows rows 4530 of surgical staples4532 that are connected the next staple in the row via an adjunctsegment 4534. The adjunct segments 4534 are shown as being in or on asupporting layer or film 4536. Such configurations, adjunct segmentswith supporting layers or films, are described in greater detail hereinelsewhere. The adjunct segments 4534 shown in FIG. 130A are located nearthe anvil-side of the staples once the staples are deployed in tissue.FIG. 130B shows row 4540 of surgical staples 4542 in use with adjunctsegments 4544 and a supporting film 4546. As in FIG. 130A, the adjunctsegments 4544 are located near anvil-side of the staples 4542. Howeverthe adjunct segments 4544 of FIG. 130B are shaped differently from thosein FIG. 130A, in that the openings for accepting staple legs are largerin FIG. 130B. This increased size can allow for slight contraction orexpansion of the tissue and the corresponding motion of the staples.FIG. 130C shows another embodiment in which rows 4550 of surgicalstaples 4552 with adjunct segments 4554 and a support film 4556 are usedtogether. The adjunct segments 4554 in FIG. 130C are different fromthose in FIGS. 130A and 130B because the adjunct segments 4554 arerings, allowing the maximum amounts of motion of the staple legs withinthe center 4558 of the adjunct segments 4554. This allows even greatermotion of the each surgical staple with regards to its neighbor, andthus the stapled tissue can accommodate greater expansion andcontraction.

FIGS. 131 and 132 show the adjunct segments 4534 and surgical staples4532 of FIG. 80A. In FIG. 131, an artery 4560 has staples 4532 andadjunct segments 4543 seal a portion of the artery 4562. FIG. 132 showsthe artery 4560, staples 4532, and adjuncts 4534. In both FIGS. 131 and132, each staple 4532 is shown connected to its neighbor throughopposite ends of an adjunct segment.

FIGS. 133-135 are similar to FIG. 131, except that each shows adifferent type or use of an adjunct segment. In FIG. 133, an artery orother type of tissue 4560 is sealed by two rows 4570 of staples 4572.The row of surgical staples 4572 at the free edge of the tissue 4562 hasthick adjunct segments 4574. The row of surgical staples 4572 furtheraway from the free edge of the tissue 4562 has thinner adjunct segments4576. The adjunct segments 4574, 4576 connect each surgical staple 4572to at least one neighboring staple. Also, the adjunct segments 4574,4576 are near the crowns of the staples 4579 when the staples aredeployed, as shown. Using different thickness adjunct segments 4574,4576 can help to prevent tissue damage and can help to promote healingof the tissue 4560 after the stapling procedure. The embodiment of rowsof staples 4580 shown in FIG. 134 is similar to that shown in FIG. 133,except that the adjunct segments 4584, 4586 are positioned near theanvil-side portions 4588 of the surgical staples 4582. The thickness ofthe adjunct segments 4584, 4586 are different, in that those adjunctsegments nearest the free edge 4562 of the tissue are thicker adjunctsegments 4584 and those away from are thinner 4586. FIG. 135 shows anembodiment of rows 4590 of surgical staples 4592 where thicker adjuncts4594, 4595 are used closer to the free edge 4562 of the tissue 4560 andthinner adjuncts are used away from the free edge 4562 of the tissue4560 to attach each staple 4592 to a neighboring staple along the lengthof the rows 4590. In the embodiment shown in FIG. 135, adjuncts 4594,4595, 4596, 4597 are located near the crowns 4599 of the staples 4592,as well as near the anvil-side portions 4598 of the staples 4592.

Staple lines that include a plurality of surgical staples and adjunctsegments that connect two surgical staples together can exhibit a myriadof configurations that correspond to a range of contraction or expansionof the underlying tissue. FIGS. 136-139 show exemplary configurationsadjunct segments and surgical staples in which each staple connects twoadjunct segments. FIG. 136 shows a staple cartridge 4600 with adjunctsegments 4604 that contact two staples 4602 when forming a staple line.The staple line includes two rows of staples that are applied parallelto the surgical cut, with the first row adjacent to a surgical cut andthe second row further away from the surgical cut. The staples in thefirst row are offset from the second row. Each adjunct segment 4604connects a staple from the first row with a staple from the second row.Because of the offset, the adjunct segments 4606 are applied in aposition that is tilted when compared to a line perpendicular to thesurgical cut, and in a relaxed state, as shown, the adjunct segments4616 are as close together as they can be, touching or nearly touching.FIG. 139 shows the progression of the configuration changes from atensioned state 4620 to a fully relaxed state 4630. In an extremelytensioned state 4620, the adjunct segments 4616 are at an angle in therange of about 0° to 90° in a position that so that the adjunct segments4616 are further away from each other than in the relaxed state 4630. Inthe intermediate state 4625 shown in FIG. 139, the adjunct segments 4616are perpendicular to the surgical cut. The relaxed state 4630 is similarto that shown in FIG. 136.

FIG. 137 shows another configuration of adjunct segments 4608 andsurgical staples 4606 in which the staples are applied along a surgicalcut at an angle. In a relaxed state 4610, such as when first applied totissue, the staples 4606 are between about 0° and 90° to the cut, suchas at about 45° to the cut, and the adjunct segments 4608 areperpendicular to the cut. When the tissue stretches, the staples 4606are at a different angle, such as about 30° from the cut. The adjunctsegments 4608 move from a position substantially perpendicular to thesurgical cut to one that is no longer perpendicular. FIG. 138A shows aside view of the relaxed configuration 4610, and FIG. 138B shows a sideview of the tensioned configuration 4612 of staples 4606 and adjunctsegments 4608.

FIGS. 140A-140B show an embodiment 4640 of surgical staples and adjunctsegments 4652 connected by a serpentine connector 4646 on an optionalsupport layer 4642. The support layer 4642 can also include adjunctsegments 4644 that are not connected. The serpentine connector 4646 isconnected to the adjunct segments 4652 at connection points 4648. Thesupport and adjunct segments 4652 shown include openings for staplelegs.

As shown in other figures described above, adjunct segments can havemany configurations. FIGS. 141A-145D show four different configurations.FIGS. 141A-141D show an adjunct segment 4690 that is symmetric, suchthat the top view and the bottom view are similar. The adjunct segment4690 includes openings 4692 for staple legs. FIG. 141A is across-sectional view of the adjunct segment 4690, FIG. 141B is an endview of the adjunct segment, FIG. 141C is a bottom view of the adjunctsegment 4690, and FIG. 141D is a top perspective view of the adjunctsegment 4690. FIGS. 142A-142D show an adjunct segment 4700 whichincludes a thicker portion 4704 in the center of the adjunct segment,between the openings 4702 for staple legs.

FIG. 143 shows an embodiment of a delivery configuration assembly 4710for adjunct segments 4712. The adjunct segments 4712 can be made asindividual components, not connected by branches or filaments, adheredto a compliant or removable backing 4714. The arrangement of the adjunctsegments 4712 on the backing 4714 can be such that mating the deliveryconfiguration assembly 4710 with a surgical stapler anvil or staplecartridge allows for perfect or near perfect alignment of the adjunctsegments 4712 with the stapler features.

FIGS. 144A-144D show an embodiment for an adjunct segment 4715 that hasa base portion 4717 and thicker portions 4716 with openings 4718. Theopenings 4718 go through the thicker portions 4716 as well as the baseportion 4717. The thicker portions 4716 may be a different material thanthe base portion 4717 or the thicker and base portions may be of thesame or similar materials. The thicker portions 4716 may prevent tissuedamage from staple legs when the tissue expands or contracts. FIGS.145A-145D show an adjunct segment 4720 that has a base portion 4722 withopenings 4726 for staple legs and portions around the openings 4724. Theopenings portions around the openings 4724 may be of a differentmaterial than the base portion 4722, or they base 4722 and the portionssurrounding the openings 4726 may be of the same material, but, becauseof their configuration, have different materials properties, such asthey may act as cushions between the adjunct segment 4720 and a surgicalstaple or tissue.

Application of Adjunct Materials

Sealant materials can be applied to tissue that is treated with surgicalstaples directly, prior to or after being treated with a surgicalstapler and endocutter as a film or a liquid as an alternative to beingapplied as an adjunct segment.

FIGS. 146-149C show an applicator for applying liquid or gel adjunctmaterial 4899 directly to an anvil or a staple cartridge of a surgicalstapler 4891. FIG. 146 shows an embodiment 4890 in which an adjunctmaterial 4899 is applied from a tube 4896, through an applicator 4897attached to the tube 4896. The adjunct material 4899 is shown on theanvil 4892. FIG. 147 shows a cross-sectional view of an applicator 4897with gel adjunct material 4894 in contact with the anvil 4892 to fillstaple forming openings 4893. FIG. 148 shows a view of an applicator4897 with a squeegee feature 4898 to apply adjunct material 4894 to ananvil 4892 to fill staple forming openings 4893 with adjunct material.FIG. 149A shows an applicator 4909 for applying adjunct material 4906from a reservoir 4908 to an anvil 4904 of a surgical stapler 4900. FIG.149B shows an alternate type of applicator 4920 for applying adjunctmaterial 4922 to an anvil 4914 of a surgical stapler 4910. The appliedadjunct material 4922 is smoothed by the applicator 4920 into the stapleforming openings 4916 to form adjuncts 4918. FIG. 149C shows theadjuncts 4918 in the staple forming openings 4916 in the anvil 4914.

FIGS. 150-154 show an applicator for applying an adjunct materialdirectly to an anvil of a surgical stapler, in which the material iscomposed of two precursors or two materials which mix prior toapplication to the anvil or staple cartridge. FIG. 150 shows anembodiment 4930 of an applicator 4942 for an adjunct material from twomaterials 4936, 4940. The applicator 4942 includes a dual syringe set4932 and a mixing nozzle 4944. The dual syringe set 4932 includesindividual syringes 4934, 4938 that interface with the applicator nozzle4946 through fittings, such as Luer fittings or threaded fittings. Theindividual syringes are shown as syringe A 4934, that can contain afirst material 4936, such as fibrin; and syringe B 4938, that cancontain a second material 4940, such as thrombin. A single plungerexpels the first and second materials into the mixing nozzle 4994 beforethe adjunct material exits through the applicator nozzle 4946. FIG. 151is a similar embodiment, but the diameters of the syringes 4952, 4954 inthe syringe set 4950 are different, so that upon application of theplunger, a ratio of materials other than 1:1 exits the syringes andmixes in a common lumen, the mixing nozzle 4958, before exiting throughthe applicator nozzle 4959.

FIGS. 152A and 152B show the interface between a syringe or othercontainer 4960 filled with an adjunct material 4962 and a portion of amixing or applicator nozzle 4963. The interface includes a fittingbetween a threaded portion 4966 of the container 4960 of adjunctmaterial 4962 and a threaded portion 4965 of the nozzle 4963. Thecontainer 4960 of adjunct material 4962 can include a seal 4961 thatkeeps the adjunct material 4962 within the container 4960 duringshipping and storage. The nozzle 4963 includes a piercing feature 4964to break the seal 4961 when the threaded portions 4965 and 4966 arefully engaged. When the threaded portions 4965 and 4966 are fullyengaged the adjunct material 4962 flows from the container 4960 into thenozzle 4963. FIGS. 153 and 154 show a dual syringe set 4932 attached toa mixing nozzle 4944 and applicator nozzle 4946, as in FIG. 150, in useapplying adjunct material 4969 to an anvil 4968 of a surgical stapler4967.

FIGS. 155-160 show fittings and which can apply liquid or gel to aportion of a surgical stapler, either to the anvil or the staplecartridge and the resulting adjunct layer. In FIG. 155 and FIG. 156, theapplicator nozzle 4977 is shown fitted over an anvil 4976. In FIG. 155,the adjunct material 4978 is a single adjunct material, that is to saythat it is not a material that needed to be mixed immediately prior toapplication. The adjunct material 4979 shown in FIG. 156 includes twoprecursors or components that are mixed immediately prior to applicationof the adjunct material to the anvil. FIG. 157 shows an anvil 4980 withstaple forming openings 4981 filled with adjunct material 4982 that wasapplied with a nozzle applicator, such as shown in FIG. 155 and FIG.156.

Adjunct material can be applied to staple cartridges used with surgicalstaplers. FIG. 158 shows an applicator nozzle 4984 coupled to a staplecartridge 4983 to apply adjunct 4985 to staples 4986 loaded in thecartridge. FIG. 159 also shows an applicator nozzle 4988 fitted to astaple cartridge 4983. In FIG. 159, the adjunct material 4987 flowingover the staple 4986 is made of two constituents or components which aremixed immediately prior to application of the adjunct material to thecartridge. FIG. 160 provides a view of applied adjunct material 4989 onstaples 4986 loaded in a stapler cartridge 4983.

FIG. 161 shows a surgical staple 4992 improperly situated inside oftissue 4991. Such a configuration 4990 can occur when no adjunctmaterial is present to distribute forces from the staple on the tissueand prevent the staple from cutting through tissue or inappropriatelycompressing the tissue. FIG. 163 shows how the presence of adjunctmaterial 4998 on the anvil-side of a staple 4997 can allow properplacement of the staple 4997 in tissue 4996.

FIG. 162 shows a stick of gel adjunct material 4994 that is applied tothe anvil 4995 or staple cartridge of a surgical stapler 4993. This isan alternate embodiment for a method for applying, and an applicator of,adjunct material. In this way, a surgical stapler can be reloaded andprepared quickly, such as when a surgeon needs to use a single surgicalstapler multiple times in a single procedure.

FIGS. 164A-164C show surgical staples 41010 used with adjuncts 41012used with a surgical stapler 41000 to transect tissue 41002. In thesurgical stapler 41000, the anvil 41004 can be loaded with adjunctsegments 41012 which interact with the staples 41010 loaded in thestaple cartridge 41006. The adjuncts 41012 in the anvil 41004 can holdstaples 41010 that are not applied to tissue 41002, as shown in FIG.164C.

Adjuncts for Anastomosis

Anastomosis is a process which requires creating a circular cut througha staple line in each end of the tissues to be connected. Cuttingthrough a staple line can cause torn or partially cut staples. Dog earsof tissue at the corners of the staple line can have leaks or allowdebris to collect, however, if it is not possible to eliminate dog earsaltogether, then it sealing them to minimize leakage is desirable.Described below are adjunct assemblies for use with specific staplecartridge configurations that include seals for dog ears, as well asprovide a minimal amount of staples through the area that is eventuallycut by a circular cutting implement.

FIG. 165 shows an embodiment of a non-continuous adjunct 41020 for usein forming an anastomosis. The non-continuous adjunct 41020 includes aring 41022, or washer, in the center of the adjunct. Attached on eitherside, 180° apart, are suture filaments 41026. The suture filamentsconnect to sealing material 41024. Each portion of sealing material41024 is configured to seal a dog ear portion of the staple line by. Thesealing material 41024 is configured to span multiple staples and onceinserted into tissue, the staple can have the sealing material 41024adjacent to the crown of the staple or adjacent to the anvil-side of thestaple. In some embodiments, the sealing material 41024 is configured tobe adjacent to the crown of staples deployed in tissue. Such sealingmaterial can be complemented with sealing material, such as adjunctsegments, on the anvil-side of the staple.

FIGS. 166 and 167 show a surgical staple cartridge 41028 and a staplepattern for use with the adjunct of FIG. 165. The staple pattern on thecartridge 41028 is shown to have areas of two or more rows of staples41030 and areas with a single row of staples 41031. The single row ofstaples 41031 is intended to, or configured to, correspond to theportion of the tissue that will be cut through in forming a circularcut. The suture filament 41026 of the non-continuous adjunct 41020 isdelivered parallel to this single row of staples 41030. The areas of twoor more rows of staples 41030 correspond to where the dog ears in thetissue will be. The sealing material 41024 of the non-continuous adjunct41020 is configured to be used with the two or more rows of staples41030, as shown in FIG. 166.

In the staple cartridge 41028 shown in FIG. 166 and the staple patternshown in FIG. 167, it can be seen that the single row of staples 41031is centered with respect to the multiple rows of staples 41030 in thedog ear area. The suture filament 41026 of the non-continuous adjunct41020 will not only be substantially parallel to the single row ofstaples 41031, but the suture filament 41026 will almost overlay thesingle row of staple 41031 once the adjunct 41020 is deployed withsurgical staples into tissue. More than one non-continuous adjunct 41020can be deployed at a time, and is shown in FIG. 166, in such situations,the non-continuous adjuncts 41020 can be substantially similar.

FIG. 168 is an illustration of an alternative embodiment of anon-continuous adjunct for use in forming an anastomosis. Shown are twonon-continuous adjuncts 41040, 41050 that are minor images of eachother. The non-continuous adjuncts 41040, 41050 each have a washer41046, 41056, attached to suture filaments 41044, 41054. The suturefilaments 41044, 41054 are attached to sealing material 41042, 41052that is configured to span multiple surgical staples in the dog ear areaof the stapled tissue.

FIGS. 169-173 show a surgical stapler cartridge 41060 for use with theadjuncts of FIG. 168, as well as further views of the non-continuousadjuncts 41040, 41050 of FIG. 168. The stapler cartridge 41060 issymmetric about a centerline, where a cut through stapled tissue can bemade. The cartridge 41060 has areas for a single row of staples 41064and for multiple rows of staples 41062 on each half of the cartridge.The multiple rows of staples 41062 are at the ends of the staple lineand are where the dog ear portion of the tissue will be. The single rowsof staples 41064 are off-center with respect to the multiple rows ofstaples 41062, such that the single rows of staples 41064 are locatedtowards the edges of the cartridge 41060. When the non-continuousadjuncts 41040, 41050 are overlaid onto the cartridge, the sealingmaterial 41042, 41052 corresponds to the areas on the cartridge 41060with multiple rows of staples 41062, the washers 41046, 41056 are eachin the center of a single row of staples 41064, each on one half of thecartridge 41060. The suture filaments 41046, 41056 are substantiallyparallel to the single rows of staples 41064, but do not overlay them.FIG. 171 shows the relative positioning of the non-continuous adjuncts41040, 41050 and staples, showing the unsealed staples 41066 of thesingle rows of staples. These unsealed staples 41066 can be cut throughor removed when an anastomosis is formed. FIG. 172 shows the view ofFIG. 171 overlaid on the view of FIG. 170. FIG. 173 includes depressionsin the staple cartridge 41060 underneath the washers 41046, 41056.

FIG. 174 shows an embodiment of an adjunct washer 41066 before andduring actuation of a surgical stapler. The washer 41066 can be onesimilar to any of the previously discussed washers, 41022, 41046, 41056.The washer 41066 is shown in a recess in a stapler cartridge 41064.Suture filaments 41068 connect to the washer 41066. When the adjunct isplaced in the surgical stapler, before staple deployment, the washer41066 is substantially circular in cross-section. During stapledeployment, the washer 41066 compresses under pressure 41070 from thesurgical stapler. The washer 41066 then has a substantially ellipticalcross-section. Under pressure, the washer 41066 becomes flush, or nearlyflush, with an upper portion of the staple cartridge while filling, ornearly filling, the recess.

FIG. 175 shows an embodiment of a surgical staple cartridge for use informing an anastomosis. This side view allows a comparison for the tipsof a standard staple cartridge 41072 and that of a LAR 41074. A personskilled in the art will appreciate that it could be useful in LARprocedures to reduce the length of the end effector distal to anarticulation joint in the stapler. It is believed that reducing thedistance from a distal most staple in the cartridge to the distal mostlocation on the staple cartridge will enable this effort as shown inFIG. 175. A person skilled in the art will be able to ascertain theappropriate relative distances.

FIG. 176 shows a body lumen transected by a surgical stapler with anadjunct, such as the one shown in 118. The tissue 41076 is shown withnon-continuous adjuncts 41040, 41050 in place. The washers 41046, 41056align, and alongside each washer 41046, 41056 and the suture filaments41044, 41054 connected to each washer is a single row of staples 41066that is not sealed by adjunct material. Sealing material 41042, 41052prevents leaks in the dog ear portions of tissue with multiple rows ofstaples.

FIGS. 177A-177C shows a cross-sectional view of the use of an adjunct41050, such as the one shown in FIG. 168 and a circular stapler trocar41078. FIG. 177A shows the non-continuous adjunct in tissue 41076 withthe washer 41056 above a staple line that includes the unsealed, singlerow of staples 41066. FIG. 177B shows the trocar 41076 approaching thestaple line 41066 and washer 41056 as it moves through a lumen in thetissue 41076. FIG. 177C shows the engagement of the trocar 41078 withthe washer 41066. FIG. 178 shows the relative positioning of all of thecomponents of the adjunct 41505 when the trocar 41078 is engaged withthe washer 41056.

FIGS. 178-186 shows a circular stapler trocar 41078 passing through awasher portion of a non-continuous adjunct 41050. FIG. 179 shows thenon-continuous adjunct 41050 with a washer 41056, suture filaments41054, and sealing material 41052 at the dog ears of the tissue 41076. Acircular staple and cutting implement 41080 is inside the tissue 41076.A trocar 41078 is at the center of the staple and cutting implement41080. The trocar 41078 extends through the washer 41056 toward a shaft41084 that is connected to an anvil 41082 in another portion of thetissue 41076 that has been cut and sealed along a staple line 41088. Theanvil 41082 is shown above a buttonhole that is adjacent the shaft41084.

FIG. 180 shows an embodiment similar to that shown in FIG. 179. In FIG.180 the non-continuous adjuncts 41040, 41050 are shown each with awasher 41046, 41056, suture filaments 41044, 41054, and sealing material41042, 41052 at the dog ears of the tissue 41076. A single row ofstaples 41066 surrounds each of the washers 41046, 41056 near the suturefilaments. A circular staple and cutting implement is inside the tissue41076, and the trocar 41078 extends through one washer 41056 towards amating shaft that extends through the other washer 41046.

FIGS. 181-183 show cross-sectional views of the movement of the sectionsof tissue 41076 toward each other, so that the tissue can be stapled(FIG. 185) and cut FIG. 186 to create an anastomosis. FIG. 181 is across-sectional view of FIG. 179, but with the shaft 41084 attached tothe anvil 41082 fitted over the trocar 41078 and in contact with thewasher 41056. FIG. 182 is a closer view of the shaft 41084 connected tothe anvil and the center portion of the adjunct 41050, particularly thewasher 41056 and suture filaments 41054. As the shaft 41084 moves down,so that the two portions of the tissue 41076 move together, the shaft41084 moves the suture filaments 41054 downward so that the sealingmaterial 41052 on the dog ears move closer together, as shown in FIG.183. FIG. 184 shows the movement of the sealing material 41052 on thedog ears toward the trocar 41078 as the shaft moves the washer 41056downward. FIG. 185 shows the tissue sections attached with staples41100. The adjunct 41050, with the washer 41056 pushed down by the shaftand the sealing material 41052 at the dog ear portion, are shown in thecenter of the stapling and cutting implement 41080. FIG. 186 shows thetissue 41076 after the circular cut has been made. The tissue is joinedwith three rows of staples 41100 in a circular configuration with thepreviously stapled tissue, including the non-continuous adjunct 41050,removed. The adjuncts 41033, 41040, 41040 described above can be usedinterchangeably or in combination in the methods for creating ananastomosis shown in FIG. 176-186.

Various exemplary bronchus sealants and methods of sealing bronchialtubes are provided. In general, the bronchus sealants and methods ofsealing bronchial tubes can facilitate sealing of stapled bronchialtubes. In some embodiments, a reinforcement material, e.g., a mesh(e.g., a knitted mesh, a non-woven mesh, or a woven mesh), a non-wovenmatrix, a film, a melt-blown non-woven material, a felt material, aclosed-cell foam, an open-cell foam, a braided suture, or a sponge, canbe introduced into a bronchial tube, and then the bronchial tube and thereinforcement material can be stapled using a surgical stapler. Asealant can be introduced into the bronchial tube and can hardentherein, thereby helping to seal the bronchial tube where the bronchialtube was stapled. Prior to hardening, the sealant can seep or wick in afirst state into the staple line, thereby facilitating complete sealingof the bronchial tube. The reinforcement material and the sealant cancooperate to provide a better, more complete seal of the staple linethan if either of the reinforcement material and the sealant were usedwithout the other. The reinforcement material at the staple line cancause inflammation of the bronchial tube, thereby causing the bronchialtube to encapsulate the reinforcement material as an irritant. Suchencapsulation can facilitate long term sealing of the bronchial tube.The reinforcement material can thus take advantage of the bronchialtube's natural inflammatory response, and natural slow healing of thebronchial tube, to help seal the stapled bronchial tube. The sealant canfacilitate short term sealing of the bronchial tube during the time thebronchial tube reacts to and encapsulates the reinforcement material,e.g., for a time period of up to about two weeks. The reinforcementmaterial that has been stapled can extend from the staple line into thebronchial tubes passageway, thereby providing the sealant with astructure within the bronchial tube to help hold the sealant in positionadjacent the applied staples while the sealant hardens within thebronchial tube and to help hold the sealant in position adjacent theapplied staples after the sealant has hardened. By being held adjacentto the staple line by the reinforcement material, the sealant can bemore likely to harden at and completely seal the staple line. Thebronchial tube can thus be more likely to remain sealed during expansionand contraction of the lung during breathing.

The sealant can be introduced into the bronchial tube before thestapling of the bronchial tube and the reinforcement material, such asby the reinforcement material being imbibed with the sealant in a firststate, e.g., as a softened state such as fluid, a gel, etc., or as a drystate, e.g., as a powder, etc. The reinforcement material being coupledto the sealant before stapling can facilitate delivery of thereinforcement material and the sealant into the bronchial tube byallowing the reinforcement material and the sealant to be simultaneouslydelivered thereto. Alternatively or in addition, the sealant can beintroduced into the bronchial tube after the stapling of the bronchialtube and the reinforcement material, such as by injection of the sealantin a first state into the bronchial tube adjacent a staple line formedby the stapling. The sealant being delivered into the bronchial tubesubsequent to the stapling can help prevent the sealant from hardeningwithin the bronchial tube before the bronchial tube is stapled. If thesealant is delivered into the bronchial tube subsequent to the stapling,the same surgical instrument that delivered the reinforcement materialinto the bronchial tube can deliver the sealant, thereby making thesurgical procedure easier to perform since only one delivery device needbe introduced into the bronchial tube.

FIG. 187 illustrates one embodiment of a surgical instrument 5000configured to deliver a reinforcement material (not shown) and a sealant(not shown) into a bronchial tube 5002 of lungs 5004 of a patient 5006.The instrument 5000 can include a proximal handle portion (not shown)configured to be held, e.g., handheld by a medical practitioner, held bya robotic surgical arm, etc., outside the patient 5006, as will beappreciated by a person skilled in the art. The instrument 5000 can beconfigured to be transorally advanced into the bronchial tube 5002, asshown in FIG. 187, by being advanced into a mouth 5008 of the patient5006. The instrument 5000 can be advanced into the patient 5006 in otherways, as will be appreciated by a person skilled in the art. Forexample, the instrument 500 can be configured to be advanced into apatient through an introducer device, such as a trocar, inserted intothe patient through an incision formed through skin of the patient.

As shown in FIG. 188, the instrument 5000 can include a scoping device5010, e.g., an endoscope, a laparoscope, etc., and an end cap 5012configured to be coupled to a distal end 5014 of the scoping device5010. The scoping device 5010 in this illustrated embodiment has oneworking channel 5016 extending longitudinally therethrough, includes onevisualization element 5058, e.g., a lens, etc., and includes two lights5018, e.g., light emitting diodes (LEDs), etc. The lights 5018 and theviewing element 5058 can be distal-facing, as in the illustratedembodiment, which can facilitate visualization of a target surgical sitedistal to the instrument 5000. In other embodiments, a scoping devicecan have a plurality of working channels extending longitudinallytherethrough and/or can have a different number of lights.

The end cap 5012 can be configured to be selectively attachable to thescoping device's distal end 5014, such as by being snap fit thereon, bybeing fit thereto via interference fit (as in the illustratedembodiment), by being threaded thereto, etc. In other words, the end cap5012 can be configured to be removably and replaceably attachable to thescoping device 5010. The end cap 5012 being configured to be selectivelyattachable to the scoping device 5010 can allow the end cap to bedisposable, can facilitate cleaning of the scoping device 5010 and/orthe end cap 5012 before reuse with another patient, and/or can helpprevent the scoping device 5010 from being damaged by sealant deliveredusing the instrument 5000. Exemplary embodiments of attachmenttechniques for attaching an end cap to a scoping device are described infurther detailed in U.S. Pat. No. 8,551,058 entitled “EndoscopicTranslumenal Surgical Systems” filed on Jul. 10, 2007, which is herebyincorporated by reference in its entirety.

The end cap 5012 can include a working port 5020, a window 5022, and aballoon 5024 around a perimeter thereof. The working port 5020 can beconfigured to be aligned with the scoping device's working channel 5016when the end cap 5012 is attached to the scoping device 5010, which canallow a surgical device (not shown) to be advanced distally through thescoping device's working channel 5016 and through the end cap's workingport 5020. The window 5022 can be configured to be aligned with thescoping device's lights 5018 when the end cap 5012 is attached to thescoping device 5010, thereby allowing the lights 5018 to shine throughthe window 5022 so as to illuminate a target surgical site distal to theinstrument 5000.

The balloon 5024 can be configured to be selectively inflatable when theend cap 5012 is attached to the scoping device 5010. The balloon 5024can be configured to move between an uninflated configuration, shown inFIG. 188 with the balloon 5024 in solid line 5026, and an inflatedconfiguration, shown in FIG. 188 with the balloon 5024 in broken line5028. When the balloon 5024 is in the uninflated configuration, the endcap 5012 can have a first diameter that is less than a second diameterof the end cap 5012 when the balloon 5024 is in the inflatedconfiguration. The balloon 5024 can be configured to be selectivelyinflated and deflated in a variety of ways. As in this illustratedembodiment, the end cap 5012 can include an inflation line 5030extending distally therefrom. The balloon 5024 can be in fluidcommunication with the inflation line 5030. The inflation line 5030 canbe configured to extend through the working channel 5016 of the scopingdevice 5010 and couple to an inflation source (not shown) at a proximalend of the scoping device 5010, as will be appreciated by a personskilled in the art. In some embodiments, the inflation line 5030 canextend through the working channel 5016 of the scoping device 5010 andbe configured to be attached to the end cap 5012 when the end cap 5012is attached to the distal end 5014 of the scoping device 5010.

The end cap 5012 can include a cleaning mechanism (not shown) configuredto clean a distal end of the instrument 5000, e.g., a distal end of thescoping device 5010 and/or a distal end of the end cap 5012, when theend cap 5012 is attached to the scoping device's distal end. Thecleaning mechanism can allow for the instrument 5000 to be cleanedwithin a patient's body such that the instrument 5000 need not beremoved for cleaning should the viewing element 5058, the lights 5018,and/or other feature become obscured, clogged, etc. during use due tofluid and/or other matter. Exemplary embodiments of cleaning mechanismsare described in further detailed in U.S. Pat. Pub. No. 2009/0270686entitled “Methods And Devices For Maintaining Visibility During SurgicalProcedures” filed on Apr. 29, 2008, and U.S. Pat. Pub. No. 2009/0234193entitled “Apparatus For Keeping Clean A Distal Scope End Of A MedicalViewing Scope” filed on Mar. 13, 2008, which are hereby incorporated byreference in their entireties.

FIGS. 189-192 illustrate an exemplary embodiment of a surgical procedurefor stapling and sealing the bronchial tube 5002 using the instrument5000. Although the procedure is illustrated with respect to the surgicalinstrument 5000 of FIGS. 187 and 188, any of the surgical instrumentsdiscussed herein can be similarly used. Similarly, although theprocedure is illustrated with respect to the bronchial tube 5002 of FIG.187, another tubular anatomical structure, e.g., a blood vessel, etc.,can be similarly treated. Also, although the procedure is illustratedwith respect to stapling, a bronchial tube (or other anatomicalstructure) can be sealed as discussed herein in conjunction with a typeof fastener other than staples, e.g., clips, sutures, energy, etc.

As shown in FIG. 189, the bronchial tube 5002 can include a tumor 5032.As will be appreciated by a person skilled in the art, treatment of thetumor 5032 can include removing a portion of the bronchial tube 5002that includes the tumor 5032 and leaving another portion of thebronchial tube 5002 within the patient 5006.

As also shown in FIG. 189, a reinforcement material 5034 can beintroduced into the bronchial tube 5002. The reinforcement material 5034can include a flexible material configured to be stapled or otherwisefastened, e.g., using clips, etc., within the bronchial tube 5002.Examples of the reinforcement material 5034 include a mesh (e.g., aknitted mesh, a non-woven mesh, or a woven mesh), a non-woven matrix, acomposite matrix including a non-woven polymer (e.g., polyglactin 910)and a knitted or woven backing material (e.g., oxidized cellulose), afilm, a melt-blown non-woven material, a felt material, a closed-cellfoam, an open-cell foam, a sponge, a braided suture, and oxidizedcellulose (e.g., oxidized regenerated cellulose (ORC)). Variousembodiments of multilayered dressings that can be used as thereinforcement material 5034 are described in U.S. Pat. Pub. No.2006/0257458 entitled “Reinforced Absorbable Multilayered HemostatisWound Dressing” filed on Apr. 10, 2006, which is hereby incorporated byreference in its entirety. The reinforcement material 5034 can beabsorbable or non-absorbable. The reinforcement material 5034 in thisillustrated embodiment includes a mesh. The mesh can be formed from anyone or more materials. In general, material suitable for implantation,such as material for a surgical suture, can be suitable for the mesh.Examples of absorbable materials that can be used, alone or in anycombination thereof, to form the mesh include poliglecaprone (e.g.,Monocryl® available from Ethicon, Inc. of Somerville, N.J.), polyglactin(e.g., polyglactin 910, such as Vicryl® available from Ethicon, Inc. ofSomerville, N.J.), polydioxanone, collagen, oxidized cellulose,glycerol, glycolide, lactide, dioxanone, trimethylene carbonate, and gutsuture. Examples of non-absorbable materials that can be used, alone orin any combination thereof, to form the mesh include polypropylene,polyethylene, polybutester fiber, stainless steel, nylon, polyester,silk, and polyvinylidene difluoride (PVDF). The reinforcement material5034 in this illustrated embodiment has a rectangular shape, but thereinforcement material 5034 can have any shape, e.g., ovular,triangular, etc.

The reinforcement material 5034 can be introduced into the bronchialtube 5002 by being advanced through the working channel 5016 of thescoping device 5010, as also shown in FIG. 189. The end cap 5012 is notattached to the scoping device 5010 in FIG. 189. A grasper 5036 graspingthe reinforcement material 5034 can be advanced through the scopingdevice's working channel 5016 so as to hold and pass the reinforcementmaterial 5034 through the working channel 5016 and out a distal endthereof so as to position the reinforcement material 5034 within thebronchial tube 5002, as shown in FIG. 189. The reinforcement material5034 can be introduced into the bronchial tube 5002 in another way, aswill be appreciated by a person skilled in the art, such as by beingadvanced through a different scoping device, advancing the reinforcementmaterial 5034 into the bronchial tube 5002 using the grasper 5036without a scoping device, etc.

The reinforcement material 5034 can be positioned at a target sitewithin the bronchial tube 5002 located on one side of the tumor 5032.The target site can be an area intended to be stapled with a surgicalstapler 5038. The stapler 5038 can be any surgical stapler configured tostaple a bronchial tube, such as a linear stapler, as shown in theillustrated embodiment. Exemplary embodiments of staplers are describedin further detail in U.S. patent application entitled “Adjunct Materialsand Methods of Using Same in Surgical Methods for Tissue Sealing” filedon even date herewith Atty. Dkt. No. 47059-253F01US (END7380USNP)),which is hereby incorporated by reference in its entirety.

The stapler 5038 can be located outside the bronchial tube 5002, asshown in FIG. 189. The stapler 5038 and the grasper 5036 can include alocation mechanism configured to help position the stapler 5038 relativeto the target site within the bronchial tube 5002 where thereinforcement material 5034 is positioned. The bronchial tube 5002 is arelatively hard member that can make it difficult, if not impossible, tolocate the grasper 5036 and/or the reinforcement material 5034 thereinby touch. In another, softer body lumen, such as the intestinal tract,the grasper 5036 and/or the reinforcement material 5034 could be locatedby external touch of the lumen, e.g., by touching the lumen with afinger, by gently pressing the stapler 5038 against the lumen, etc.

The location mechanism can have a variety of configurations. Exemplaryembodiments of location mechanisms that can be used to facilitatepositioning of a stapler are described in U.S. Pat. Pub. No.2012/0024934 entitled “Transwall Visualization Arrangements And MethodsFor Surgical Circular Staplers” filed on Jul. 30, 2010, which is herebyincorporated by reference in its entirety.

For example, the location mechanism can include a light illuminatedwithin the bronchial tube 5002 that can be detectable from outside thebronchial tube 5002. For example, the lights 5018 of the scoping device5010 can be configured to be bright enough to be visually detectablefrom outside the bronchial tube 5002. For another example, the locationmechanism can include a light (not shown) illuminated from outside thebronchial tube 5002 that can allow location of the grasper 5036 and/orthe reinforcement material 5034 within the bronchial tube 5002 to bevisually identified, such as by the stapler 5038 including a light (notshown) and/or a second scoping device (not shown) located outside thebronchial tube 5002 including one or more lights similar to the lights5018 of the scoping device 5010. For yet another example, the locationmechanism can include one or more magnets, such as rare earth magnets,located within the bronchial tube 5002, e.g., by being attached to thegrasper 5036, by being attached to detection members (e.g., lights,extendable bumpers, etc.) coupled to the scoping device 5010, etc. Aprobe (e.g., a Hall effect sensor, etc.) positioned near the tumor 5032side of the bronchial tube 5002 can be configured to measure a distancebetween the magnet(s) and the tumor 5032, thereby indicating a locationfor stapling of the bronchial tube 5002. The probe can be attached tothe stapler, e.g., to a distal tip of an anvil of the stapler. Themagnet(s) can be configured to alternate in polarity and/or vary inintensity, which can facilitate the probe's measurement of the distanceby allowing the probe to detect distance and orientation.

In this illustrated embodiment, the location mechanism includes a magnet5040 coupled to the grasper 5036 and a sensor (not shown), e.g., aproximity sensor, a Hall effect sensor, etc., coupled to the stapler5038 and configured to sense the magnet 5040 coupled to the grasper 5036when the sensor is within a certain predetermined distance of the magnet5040. In this way, the sensor being positioned near the magnet 5040disposed within the bronchial tube 5002, so as to sense the magnet 5040,can indicate that the stapler 5038 is adjacent the reinforcementmaterial 5034 within the bronchial tube 5002. In other words, thedetection of the magnet 5040 by the sensor can indicate that the stapler5038 is at a position relative to the bronchial tube 5002 at which thestapler 5038 can staple the bronchial tube 5002. The sensor sensing themagnet 5040 can be configured to trigger a notification at a proximalend (not shown) of the stapler 5038 when the stapler's magnet ismagnetically attracted to the magnet 5040, which can help indicate to auser of the stapler 5038 that the stapler 5038 is positioned adjacentthe target site. The notification can include, e.g., a light, a sound, avibration, etc. The grasper 5036 includes one magnet 5040 in thisillustrated embodiment, but the grasper 5036 can each include any numberof magnets. Although the grasper 5036 includes the magnet 5040 in thisillustrated embodiment, another element, such as the scoping device 5010(e.g., the distal end 5014 thereof), the reinforcement material 5034,etc., can include the magnet 5040 and/or can include one or moreadditional magnets. In an exemplary embodiment, the magnet 5040 can becoupled to an element that is not implanted within the bronchial tube5002, e.g., on a surgical device used to deliver the reinforcementmaterial 5034 and/or a sealant to the bronchial tube 5002, which canhelp prevent the location mechanism from interfering with any subsequentsurgical procedures.

When the stapler 5038 is positioned at a desired location relative tothe bronchial tube 5002, e.g., adjacent the target site where thereinforcement material 5034 is within the bronchial tube 5002, thestapler 5038 can staple the bronchial tube 5002 and the reinforcementmaterial 5034 by ejecting one or more staples 5042 therefrom, as shownin FIG. 190. The stapler 5038 in this illustrated embodiment ejects sixstaples 5034, but the stapler 5038 can eject any number of staples,simultaneously or sequentially. The stapler 5038 can also, as will beappreciated by a person skilled in the art, cut the stapled bronchialtube 5002 using a knife or other cutting element. The cutting of thebronchial tube 5002 can result in a specimen portion 5044 of thebronchial tube 5002, which includes the tumor 5032 and which can beremoved from the patient 5006, and a remainder portion 5046 of thebronchial tube 5002, which can remain within the patient 5006. As shownin FIG. 191, the stapling and cutting can form first and second staplelines 5052 a, 5052 b in the bronchial tube, with the first staple line5052 a being formed in the specimen portion 5044 and the second stapleline 5052 b being formed in the remainder portion 5052 b.

As mentioned above, the stapler 5038 can staple the reinforcementmaterial 5034 when the stapler 5038 staples the bronchial tube 5002. Thestapler 5038 can thus cut the reinforcement material 5034 when thestapler 5038 cuts the bronchial tube 5002. A first portion 5048 of thereinforcement material 5034 can be in the specimen portion 5044 afterbeing stapled and cut and can be removed from the patient 5006 with thespecimen portion 5044. A second portion 5050 of the reinforcementmaterial 5034 can be in the remainder portion 5046 and can remain in thebronchial tube 5002 after being stapled and cut, as shown in FIG. 191.The second portion 5050 of the reinforcement material 5034 within thebronchial tube 5002 can extend from the staple line 5052 b into thebronchial tube 5002.

As shown in FIG. 191, a sealant 5054 can be introduced into thebronchial tube 5002. The sealant 5054 can include a material configuredto transition from a first state to a second state in which the materialis harder than in the first state. The first state can thus be asoftened state or a dry state, and the second state can be a second,harder state, e.g., hardened as a solid, a rigid member. The sealant5054 can be configured to transition from the first state to the second,harder state in a predetermined amount of time. As will be appreciatedby a person skilled in the art, the predetermined amount of time canvary based on the substance(s) forming the sealant 5054. Examples of thesealant 5054 include one or a combination of one or more of an adhesive,fibrin thrombin, a hydrogel, fibronectin, gelatin, collagen, FactorXIII, transglutaminase, polyethylene glycol (e.g., Progel® Pleural AirLeak Sealant available from Davol Inc. of Providence, R.I.), alginate,carboxymethylcellulose, methylcellulose, hydroxypropylmethyl cellulose,pectin, polyvinyl alcohol, polyvinylpyrrolidone, benzocaine (e.g.,Projel-20™ available from Septodont of Lancaster, Pa.), cyanoacrylate,polyglycolic acid, hyaluronic acid, magnesium peroxide, 2 octylcyanoacrylate (e.g., Dermabond® available from Ethicon, Inc. ofSomerville, N.J.), and hydrogen peroxide. In another embodiment, thesealant can be blood, such as autologous blood. Exemplary embodiments ofsealants are described in further detail in U.S. patent applicationentitled “Methods And Devices For Sealing A Body Lumen” filed on evendate herewith (Atty. Dkt. No. 47059-254F01US (END7381USNP)), which ishereby incorporated by reference in its entirety.

The sealant 5054 can be introduced into the bronchial tube 5002 by beingadvanced through the working channel 5016 of the scoping device 5010, asalso shown in FIG. 191. The sealant 5054 can be advanced into thebronchial tube 5002 in the first state, as also shown in FIG. 191.

The end cap 5012 can be attached to the scoping device 5010 when thesealant 5054 is delivered into the bronchial tube 5002, as also shown inFIG. 191. If the end cap 5012 is not already attached to the scopingdevice 5010, e.g., when the reinforcement material 5034 is introducedinto the bronchial tube 5002, the scoping device 5010 can be removedfrom the bronchial tube 5002 after delivering the reinforcement material5034, and the end cap 5012 can be attached to the distal end 5014 of thescoping device 5010. The end cap 5012 being attached to the scopingdevice 5010 when the sealant 5054 is delivered into the bronchial tube5002 can help protect the scoping device 5010 from damage by helping tokeep the sealant 5054 from contacting the scoping device 5010 andhardening thereon. Hardened sealant 5054 on the scoping device 5010 cancause damage to the scoping device 5010 by, e.g., clogging the workingchannel 5016 and/or obscuring the lights 5018. If the sealant 5054contacts the end cap 5012 and hardens thereon, the end cap 5012 can bedisposed of at typically much lower monetary cost than disposing thescoping device 5010 and/or the end cap 5012 can be more easily cleanedthan the scoping device 5010 since, e.g., the end cap 5012 is smallerthan the endo scope 5010.

An applicator 5056 can be slidably advanced through the scoping device'sworking channel 5016 and deliver the sealant 5054 therethrough. Theapplicator 5056 can have a variety of configurations. In thisillustrated embodiment, the applicator 5056 includes an elongate tubethrough which the sealant 5054 can pass.

The sealant 5054 can be directed toward the staple line 5052 b. Thesealant 5054 can thus be directed toward the second portion 5050 of thereinforcement material 5034 extending from the staple line 5052 b. Theapplicator 5056 can be advanced through the scoping device's workingchannel 5016 and out the end cap's working port 5020, as shown in FIG.191, to facilitate directing the sealant 5054 toward the reinforcementmaterial 5034. The lights 5018 of the scoping device 5010 can be on andcan shine through the end cap's window 5022, as shown in FIG. 191, whichcan facilitate visualization of the applicator 5056, the reinforcementmaterial 5034, and/or the sealant 5054 using the viewing element 5058,which can help the sealant 5054 be directed toward the staple line 5052b.

The sealant 5054 can be introduced into the bronchial tube 5002 so as tobe applied to the reinforcement material 5034 and/or an interior tissuesurface of the bronchial tube 5002. The reinforcement material 5034 canprovide an object within the bronchial tube 5002 for the sealant 5054 toattach to, thereby helping to ensure that the sealant 5054 hardensadjacent the staple line 5052 b, thereby helping to seal the staple line5052 b. In an exemplary embodiment, the sealant 5054 is applied to boththe reinforcement material 5034 and the interior tissue surface of thebronchial tube 5002, as shown in FIGS. 191 and 192.

The sealant 5054 can be configured to transition from the first state inwhich it is delivered into the bronchial tube 5002, as shown in FIG.191, to the second, harder state, as shown in FIG. 192. The sealant 5054being introduced into the bronchial tube 5002 in the first state canallow the sealant 5054 to seep or wick into the staple line 5052 b andinto the reinforcement material 5034, which can facilitate sealing ofthe staple line 5052 b so as to help prevent a leak. The sealant 5054 inthe hardened state being coupled to the reinforcement material 5034, asshown in FIG. 192, can help keep the sealant 5054 in position within thebronchial tube 5002 where the sealant 5054 is helping to seal the stapleline 5052 b.

The balloon 5024 can be in the inflated within the bronchial tube 5002when the sealant 5054 is being advanced out of the applicator 5056, asshown in FIG. 191. In other words, the balloon 5024 can be in theinflated configuration during delivery of the sealant 5054 into thebronchial tube 5002. The balloon 5024 being inflated during delivery ofthe sealant 5054 can help prevent the sealant 5054 from blowing backproximally after being advanced distally from the applicator 5056 byfilling any excess space between the end cap 5012 and the interiorsurface of the bronchial tube 5002, can help prevent the sealant 5054from hardening within the bronchial tube 5002 at a location that couldpotentially interfere with the bronchial tube's ordinary function duringbreathing, can help hold the end cap 5012 in a fixed position relativeto the bronchial tube 5002 during delivery of the sealant 5054 so as tofacilitate introduction of the sealant 5054 into the bronchial tube 5002at a desired location, and/or can help direct all of the sealant 5054toward the staple line 5052 b.

The balloon 5024 can be in the uninflated configuration when the end cap5012 is advanced into bronchial tube 5002 and can be moved from theuninflated configuration to the inflated configuration after the end cap5012 has been positioned within the bronchial tube 5002 adjacent thestaple line 5052 b. The balloon 5024 can be expanded within thebronchial tube 5002 using the inflation line 5030, e.g., by passing afluid (e.g., air, water, etc.) through the inflation line 5030 and intothe balloon 5024. The balloon 5024 being in the uninflated configurationduring advancement of the end cap 5012 through the patient's mouth 5008and through advancement of the end cap 5012 to the target site withinthe bronchial tube 5002 can allow the end cap 5012 to have a smallerouter diameter, which can facilitate passage of the end cap 5012 throughthe patient's body.

If the end cap 5012 is attached to the scoping device 5010 when thereinforcement material 5034 is advanced into the bronchial tube 5002,the balloon 5024 can be in the inflated configuration when thereinforcement material 5034 is being advanced into the bronchial tube5002. The balloon 5024 being inflated during delivery of thereinforcement material 5034 can help prevent the reinforcement material5034 from blowing back proximally after being advanced distally from thescoping device 5010 by filling any excess space between the end cap 5012and the interior surface of the bronchial tube 5002 and/or can help holdthe end cap 5012 in a fixed position relative to the bronchial tube 5002during delivery of the reinforcement material 5034 so as to facilitatepositioning the reinforcement material 5034 at a desired location.

After the sealant 5054 has been delivered into the bronchial tube 5002,the scoping device 5010, the end cap 5012 (if attached to the scopingdevice 5010 during sealant 5054 delivery), and any devices within thescoping device's working channel 5016, e.g., the applicator 5056, can beremoved from the bronchial tube 5002. FIG. 192 shows the removal of thescoping device 5010, the end cap 5012, and the applicator 5056 from thebronchial tube 5002 in a direction shown by a retraction arrow 5060. Theapplicator 5056 is removed from the bronchial tube 5002 simultaneouslywith the scoping device 5010 and the end cap 5012 in this illustratedembodiment, but the applicator 5056 can be removed from the bronchialtube 5002 before the scoping device 5010 and the end cap 5012, e.g., bybeing withdrawn from the working channel 5016. Although FIG. 192 showsthe scoping device 5010, the end cap 5012, and the applicator 5056 beingremoved from the bronchial tube 5002 after the sealant 5054 hastransitioned from the first state to the second, harder state, any ofthe scoping device 5010, the end cap 5012, and the applicator 5056 canbe removed prior to the sealant 5054 completing the transition to thehardened state. Keeping at least the scoping device 5010 within thebronchial tube 5002 until the sealant 5054 has transitioned to thehardened state can help ensure that the sealant 5054 hardens in theproper location adjacent the staple line 5052 b, e.g., by allowingvisualization of the sealant 5054 within the bronchial tube 5002 usingthe viewing element 5058.

In some embodiments, the reinforcement material 5034 can include sealantcoupled thereto prior to the reinforcement material 5034 being stapled.For example, the reinforcement material 5034 can have a sealant coupledthereto, e.g., imbibed therein, soaked therein, coated thereon, etc.,when the reinforcement material 5034 is advanced into the bronchial tube5002. For another example, the reinforcement material 5034 can include acomposite matrix (e.g., the composite matrix mentioned above including anon-woven polymer and a knitted or woven backing material) coated orimpregnated with a sealant such as lyophilized fibrinogen and thrombin,a non-woven support. By the reinforcement material 5034 includingsealant prior to the stapling thereof, the surgical procedure caninclude fewer steps since sealant need not be separately delivered afterthe stapling. However, even if the reinforcement material 5034 includessealant prior to the stapling thereof, sealant can be delivered afterthe stapling, which can help ensure complete sealing of the staple line5052 b. For example, sealant coupled to the reinforcement material 5034can include a first component, and sealant delivered subsequent todelivery of the reinforcement material 5034 can include a secondcomponent configured to activate the first component when in contacttherewith. The second component activating the first component cantrigger the transitioning from the first state to the hardened state soas to create a third material that acts as the sealant. In this way,timing of hardening of the sealant can be user-controlled by preventinghardening of the sealant until the second component is introduced to thefirst component, which can help prevent premature hardening of thesealant before the reinforcement material 5034 is desirably positionedand/or before stapling occurs. Delivering the sealant as multiplecomponents can ease delivery of the sealant through the relatively smalldiameter bronchial tube 5002 by allowing the sealant to be introducedtherein in multiple parts. In other words, less sealant material can bepassed through the tube 5002 at any given time. Delivering the sealantas multiple components can be less expensive monetarily than introducinga singular sealant material into the bronchial tube 5002 since amountsof the sealant introduced can be better controlled and/or less of a moreexpensive component can be introduced than a less expensive component.Exemplary embodiments of multi-component sealants configured to beactivated are described in further detail in previously mentioned U.S.patent application entitled “Methods And Devices For Sealing A BodyLumen” filed on even date herewith (Atty. Dkt. No. 47059-254F01US(END7381USNP)), which is hereby incorporated by reference in itsentirety.

FIGS. 193 and 194 illustrate another embodiment of a reinforcementmaterial 5062 and a sealant 5064. In this illustrated embodiment, asshown in FIG. 193, the reinforcement material 5062 is coupled to thesealant 5064 prior to stapling of the reinforcement material 5062 and abronchial tube 5066 within which the reinforcement material 5062 can bepositioned. The reinforcement material 5062 in this illustratedembodiment includes a sponge. The sealant in 5064 in this illustratedembodiment includes a therapeutic agent, e.g., a biologic, soaked intothe sponge. The sealant 5064 being coupled to the reinforcement material5062 prior to stapling thereof can help the sealant 5064 seal a stapleline in the bronchial tube 5066 since the sealant 5064 can be positionedwithin the bronchial tube 5066 at a location of the staple line prior toformation of the staple line. The sealant 5064 including a therapeuticagent can help facilitate healing, as will be appreciated by a personskilled in the art.

The reinforcement material 5062 can be advanced into the bronchial tube5066 similar to that discussed above regarding the reinforcementmaterial 5034 of FIGS. 189-192. The scoping device 5010 of FIGS. 188-192and the grasper 5036 of FIGS. 189 and 190 are shown advancing thereinforcement material 5062 into the bronchial tube 6066, but theseand/or other devices can be used to introduce the reinforcement material5062 into the bronchial tube 5066, as discussed above. Similarly, thestapler 5038 of FIGS. 189 and 190 is shown stapling the bronchial tube5066, the reinforcement material 5062, and the sealant 5064 in FIG. 194,but a different stapler or a device applying a different type offastener can be used to cut and secure a portion of the bronchial tube5066. The bronchial tube 5066 in this illustrated embodiment has a tumor5068 therein that is being excised, thereby prompting introduction ofthe reinforcement material 5062 and the sealant 5064 therein, but abronchial tube can be treated for this and/or another reason using anyreinforcement material and any sealant described herein.

The sealant 5064 can be sufficient sealant to seal the staple lineformed by the stapler 5038. However, as mentioned above, additionalsealant (not shown), such as an activator of the sealant 5064 previouslydelivered, can be introduced into the bronchial tube 5066 and deliveredadjacent to the staple line so as to facilitate sealing thereof. Theadditional sealant can be advanced into the bronchial tube 5066 in avariety of ways, such as by the using the applicator 5056 of FIGS. 191and 192 discussed above.

In some embodiments, a bronchial tube can be stapled, or otherwise cutand fastened, before a reinforcement material or a sealant areintroduced into the bronchial tube. Stapling or otherwise fastening thebronchial tube before introducing the reinforcement material or thesealant are introduced therein can allow the bronchial tube to bestapled without a chance of the bronchial tube being stapled at alocation where the reinforcement material is not positioned.

FIG. 195 illustrates another embodiment of a surgical instrument 5070configured to deliver a reinforcement material (not shown) and a sealant(not shown). The instrument 5070 can include a proximal handle portion5074 configured to be held outside the patient 5072. The instrument 5070can be configured to be transorally advanced into the patient 5072, asshown in FIG. 195, by being advanced into a mouth 5076 of the patient5072, although the instrument 5070 can be advanced into the patient 5072in other ways that will be appreciated by a person skilled in the art.

The instrument 5070 can be configured to deliver the reinforcementmaterial and the sealant into a bronchial tube after the bronchial tubehas been stapled or otherwise cut and fastened. FIG. 196 shows anembodiment of a stapler 5078 including a pair of jaws 5080 a, 5080 bpositioned on opposite sides of a bronchial tube 5082 of the patient5072. As mentioned above, the stapler 5078 can have a variety ofconfigurations. FIG. 197 shows the bronchial tube 5082 after beingstapled by the stapler 5078. The stapler 5078 can cut the bronchial tube5082 when stapling and accordingly create first and second staples lines5084 a, 5084 b at facing ends of the cut bronchial tube 5082. Thecutting of the bronchial tube 5082 by the stapler 5078 can result in aspecimen portion 5082 a of the bronchial tube 5082, which includes thefirst staple line 5084 a and can be removed from the patient 5072, and aremainder portion 5082 b of the bronchial tube 5082, which can includethe second staple line 5084 b and can remain within the patient 5072.

As shown in FIG. 198, the instrument 5070 can be configured to beadvanced into the remainder portion 5082 b of the bronchial tube 5082. Adistal end 5070 d of the instrument 5070, also shown in FIG. 199, can bepositioned adjacent the second staple line 5084 b. The instrument 5070can include a first chamber 5090 configured to have a sealant 5086disposed therein when the distal end 5070 d is advanced into thebronchial tube 5082, and can include a second chamber 5092 configuredhave a reinforcement material 5088 disposed therein when the distal end5070 d is advanced into the bronchial tube 5082. In this illustratedembodiment, the sealant 5086 includes a fibrin and the reinforcementmaterial 5088 includes ORC, but as mentioned above, the sealant 5086 andthe reinforcement material 5088 can have other configurations. When thereinforcement material 5088 is acidic, such as when it includes ORC, thereinforcement material 5088 can provide an anti-microbial benefit duringhealing of the bronchial tube 5082, which can help reduce infectionand/or other complications from the stapling. The first chamber 5090 inthis illustrated embodiment includes a passageway of a tubular shaft5094 extending longitudinally through the instrument 5070. The secondchamber 5092 in this illustrated embodiment includes a cavity formed ina distal-most portion of the instrument 5070. The instrument 5070 canalso include a piston 5096 configured to release the reinforcementmaterial 5088 from the second chamber 5092, as discussed further below.In general, the piston 5096 can be slidably movable relative to thetubular shaft 5094 so as to move the reinforcement material 5088 out ofthe second chamber 5092 and out of the instrument 5070.

The instrument 5070 can be configured to advance the sealant 5086 andthe reinforcement material 5088 into the bronchial tube 5082 adjacentthe staple line 5082 b. As shown in FIG. 200, when the instrument'sdistal end 5070 d is positioned adjacent the staple line 5084 b, thesealant 5086 can be released from the first chamber 5090 so as to bedelivered into the bronchial tube 5082 at the staple line 5086. Thesealant 5086 can seep or wick into the staple line 5082 b, as discussedabove. The sealant 5086 can be released from the first chamber 5090 in avariety of ways, as will be appreciated by a person skilled in the art.For example, a force can be applied to the first chamber 5090 in adistal direction, e.g., air pushed into the first chamber 5090 throughan open proximal end (not shown) of the tubular shaft 5094 so as to pushthe sealant 5086 out a distal end of the tubular shaft 5094. All of thesealant 5086 can be released from the first chamber 5090 or, as shown inFIG. 200, only a portion of the sealant 5086 can be released from thefirst chamber 5090 so as to be disposed within the bronchial tube 5082.

As shown in FIGS. 200 and 201, when the instrument's distal end 5070 dis positioned adjacent the staple line 5084 b, the reinforcementmaterial 5088 can be released from the second chamber 5092 so as to bedelivered into the bronchial tube 5082 at the staple line 5086. Thereinforcement material 5088 can be released from the second chamber 5092in a variety of ways, as will be appreciated by a person skilled in theart. For example, the piston 5096 can be advanced distally, as shown bydirectional arrows 5098 in FIG. 200, so as to push the reinforcementmaterial 5088 out an open distal end of the instrument 5070. The piston5096 can be slidably disposed around the tubular shaft 5094, asmentioned above, and slid relative thereto to release the reinforcementmaterial 5088 without also causing release of the sealant 5086. All ofthe reinforcement material 5088 can be released from the second chamber5092, as in this illustrated embodiment, or only a portion of thereinforcement material 5088 can be released from the second chamber 5092so as to be disposed within the bronchial tube 5082.

The sealant 5086 can be applied only before the reinforcement material5088, the sealant 5086 can be applied only after the reinforcementmaterial 5088, or the sealant 5086 can be applied both before and afterthe reinforcement material 5088. Application of the sealant 5086 afterthe application of the reinforcement material 5088 can allow the sealant5086 to seep or wick into any space between the reinforcement material5088 and an internal surface of the bronchial tube 5082, thereby furtherfacilitating sealing. In this illustrated embodiment, the sealant 5086is applied both before and after the reinforcement material 5088. FIG.200 shows a first application of the sealant 5086 before application ofthe reinforcement material 5088, and FIG. 201 shows a second applicationof the sealant 5086 after the application of the reinforcement material5088.

In an embodiment in which the sealant is blood, such as autologousblood, the blood can be harvested from the patient and applied to theadjunct material. By way of non-limiting example, the adjunct materialcan be ORC, a known hemostatic agent, and the application of the bloodto the ORC adjunct will cause the formation of a clot, resulting in aneffective sealing structure. A person skilled in the art will appreciatethat blood, such as autologous blood can be applied to a variety ofadjunct materials to provide an enhanced sealing structure. Further, aperson skilled in the art will appreciate that the volume of bloodapplied to the adjunct will vary depending upon a number of factors,including the type and location of tissue as well, the age and conditionof the patient, and the identity of the adjunct. Generally, however,when the adjunct is an ORC material, the blood can be applied in anamount in the range of about 5-10 cc per line of staple used to affixthe adjunct to the tissue.

A person skilled in the art will appreciate that the methods, devices,systems, and apparatus described herein application in conventionalminimally-invasive and open surgical instrumentation as well applicationin robotic-assisted surgery.

As will be appreciated by persons skilled in the art, various surgicalstaplers known in the art can be used to form an anastomosis. Ingeneral, referring back to FIG. 7, a surgical stapler 200 includes ahandle assembly 212 with a shaft 214 extending distally therefrom, anend effector 250 being disposed on a distal end thereof for treatingtissue. The end effector 250 can include a cartridge assembly 252 and ananvil 254, each having a tissue-contacting surface 260 p, 260 d that issubstantially circular in shape. The cartridge assembly 252 and anvil254 can be coupled together via a shaft 262 extending from the anvil 254to the handle assembly 212 of the stapler 200, and manipulating anactuator 222 on the handle assembly 220 can retract and advance theshaft 262 to move the anvil 254 relative to the cartridge assembly 252.In one embodiment, the shaft 262 can be formed of first and secondportions (not shown) configured to releasably couple together to allowthe anvil 254 to be detached from the cartridge assembly 252, allowinggreater flexibility in positioning the anvil 254 and the cartridgeassembly 252 in a body. For example, the first portion of the shaft canbe disposed within the cartridge assembly 252 and extend distallyoutside of the cartridge assembly 252, terminating in a distal matingfeature. The second portion of the shaft 214 can be disposed within theanvil 254 and extend proximally outside of the cartridge assembly 252,terminating in a proximal mating feature. In use, the proximal anddistal mating features can be coupled together to allow the anvil 254and cartridge assembly 252 to move relative to one another. The anvil254 and cartridge assembly 252 can perform various functions and can beconfigured to capture tissue therebetween, staple the tissue by firingof staples from a cartridge assembly 252 and/or can create an incisionin the tissue. In general, the cartridge assembly 252 can house acartridge containing the staples and can deploy staples against theanvil 254 to form a circular pattern of staples around a circumferenceof a tubular body organ.

The handle assembly 212 of the stapler 200 can have various actuatorsdisposed thereon that can control movement of the stapler. For example,the handle assembly 212 can have a rotation knob 226 disposed thereon tofacilitate positioning of the end effector 250 via rotation, and/or atrigger 222 for actuation of the end effector 250. Movement of thetrigger 222 through a first range of motion can actuate components of aclamping system to approximate the jaws, i.e. move the anvil 254 towardthe cartridge assembly 252. Movement of the trigger 222 through a secondrange of motion can actuate components of a firing system to cause thestaples to deploy from the staple cartridge assembly 252 and/or causeadvancement of a knife to sever tissue captured between the cartridgeassembly 252 and the anvil 254.

The surgical stapler 200 is only one example of many different staplersthat can be used in conjunction with the sealant and sealing cuffsdisclosed herein. Further detail on the illustrated embodiment, as wellas additional exemplary embodiments of surgical staplers, componentsthereof, and their related methods of use, that can be used inaccordance with the present disclosure include those devices,components, and methods provided for in U.S. Publication No.2013/0256377, U.S. Pat. Nos. 8,393,514, 8,317,070, 7,143,925, each ofwhich is incorporated by reference herein in its entirety.

Sealing Cuff

A sealing cuff is provided herein that can be positioned around atubular body organ and can act as a mold for a sealant when the sealantis in the first, liquid state. The sealing cuff can have various sizes,shapes, but is generally configured to be positioned around ananastomosis of a tubular organ. In general, the sealing cuff can beformed from a spherical-shaped member with truncated proximal and distalends. The sealing cuff can include a central portion and first andsecond flared portions. The central portion of the cuff can correspondto a shape of a tubular body organ, while the first and second flaredportions can facilitate movement of the cuff along the tubular organbefore sealant is delivered thereto. In one embodiment shown in FIGS.202A-202C, a sealing cuff 6000 can have a substantially circularcross-sectional shape taken along a central longitudinal axis LC of thecuff 6000. The central portion 6002 of the sealing cuff 6000 can have aninner surface 6004 configured to directly contact or be positionedadjacent to an outer surface of a tubular body organ (not shown). Theinner surface 6004 can define an interior chamber 6006 for receiving asealant therein. For example, the inner surface 6004 of the sealing cuff6000 can have a substantially concave shape that defines the interiorchamber 6006. As a result, sidewall edges of the sealing cuff cancontact tissue to hold a sealant within the interior chamber of thecuff. The sealing cuff 6000 can have various features for facilitatingeven distribution of sealant within the interior chamber 6006. Forexample, the sealing cuff 6000 can include any number of protrusions6008 formed on the inner surface 6004 of the sealing cuff 6000. Ingeneral, the protrusions 6008 can be configured to directly contact anouter surface of a tubular body organ when the sealing cuff 6000 ispositioned around the organ and can prevent gravity from pulling sealanttoward a low portion of the sealing cuff 6000. The protrusions 6008 canbe shaped in various ways, such as cylindrical, spherical, conical,etc., and can have a radial height selected so that a terminal end 6008t of the protrusion 6008 directly contacts the outer surface of thetubular body organ. The protrusions 6008 can also be spaced apart invarious ways, such as around a circumference of the sealing cuff 6000 ina single row or in multiple rows, e.g. two rows, three rows, four rows,etc. The protrusions 6008 can be spaced evenly around the circumferencein a single plane or can be spaced in any other pattern configured tofacilitate an even distribution of sealant within the interior chamber6006 of the sealing cuff 6000. The protrusions can have a radial heightsubstantially equal to or larger than a radial thickness between theinner surface of the sealing cuff and the outer surface of the bodylumen to help achieve a uniform thickness of sealant around thecircumference of the cuff. As shown in FIG. 202C, the sealing cuff 6000can further include first and second flared portions positioned 6010 a,6010 b on either side of the central portion 6002 of the cuff 6000 andhaving an inner diameter DF that is greater than the inner diameter DIof the central portion 6002 of the cuff 6000. These flared portions 6010a, 6010 b can facilitate sliding the cuff around a tubular body organ,as will be discussed in greater detail. By way of non-limiting example,the inner diameter DF of the flared portions can be about 95% of theinner diameter DI of the central portion of the cuff. The sealing cuff6000 can have a relatively thin wall, for example, with a thickness inthe range of about 1 to 5 mm. An inner diameter DI of the cuff cancorrespond to, e.g. be greater than or equal to, an outer diameter of atubular body organ. For example, the inner diameter DI of the sealingcuff 6000 can be in the range of about 19 to 35 mm.

The sealing cuff can have variety of features that allow it to bepositioned around a tubular organ and then removed from the organ. Forexample, the sealing cuff 6000 in FIGS. 202A-202C can be substantiallyring-shaped when the cuff 6000 inserted in a patient. One or morereinforcement ribs 6012, 6014 can extend between and substantiallyperpendicular to the first and second flared portions 6010 a, 6010 b. Inorder to facilitate removal of the cuff 6000 from an organ, the sealingcuff 6000 can have a breakaway portion (not shown) configured tofracture or tear when a pulling force is applied to the cuff 6000. Thisbreakaway portion can be positioned in the narrow space between thefirst and second reinforcement ribs 6012, 6014, as shown in FIG. 202B.As will be appreciated by persons skilled in the art, the breakawayportion can be formed from a different, weaker material than theremaining portion of the sealing cuff 6000, e.g. different from thematerial forming central portion 6002 of the sealing cuff 6000 and/orthe reinforcement ribs 6012, 6014. The sealing cuff 6000 can furtherinclude a plurality of tabs that can be grasped by a tool to helpposition the sealing cuff 6000 and/or remove the sealing cuff 6000 froman organ. For example, as shown in FIG. 202A, a first tab 6012 a can beformed on a first terminal end of the first reinforcement rib 6012 and asecond tab 6012 b can be formed on a second terminal end of the firstreinforcement rib 6012. Similarly, a third tab 6014 a can be formed on afirst terminal end of the second reinforcement rib 6014 and a fourth tab6014 b can be formed on a second terminal end 6014 b of the secondreinforcement rib 6014. Each of the tabs 6012 a, 6012 b, 6014 a, 6014 bcan have a substantially rectangular cross-sectional shape with arelatively thin thickness so that the tabs 6012 a, 6012 b, 6014 a, 6014b can be grasped by one or more tools.

The sealing cuff can be configured to move in other ways and need notinclude a breakaway portion. For example, the sealing cuff can pivotbetween an open position in which first and second ends of sealing cuffare separated and a closed position in which first and second ends ofsealing cuff are joined together. In this way, when the sealing cuff isin the closed position, the sealing cuff is ring-shaped and defines theinterior chamber for receiving sealant. The sealing cuff can include anynumber of features to facilitate pivotable movement of the sealing cuff,such as a pivot-type hinge and one or more locking mechanisms configuredto lock the sealing cuff in the closed position.

A sealing cuff can include one or more ports for receiving sealanttherein and for directing the sealant to the interior chamber of thecuff. For example, the sealing cuff 6000 of FIG. 202A includes a port6024 having a delivery tube 6026 coupled thereto for delivering sealantto the cuff 6000. The port 6024 can be positioned so that it extendssubstantially parallel to the central longitudinal axis LC of thesealing cuff 6000 so as to minimize a diameter DP of the sealing cuff6000 at the port 624. As shown in FIG. 202C, the port 6024 can include apassageway 6028 extending into the inner surface 6004 of the cuff 6000,the passageway 6028 having a mating feature 6030 configured to mate withthe delivery tube 6026. The delivery tube 6026 can be configured tocouple to the mating feature 6030 in various ways, such as via apress-fit or a snap-fit, so that the delivery tube 6026 can be removedand cleaned or replaced after a single use. The passageway 6028 can beshaped in various ways, but in the illustrated embodiment includes afirst portion 6028 a that is perpendicular to a second portion 6028 bfor receiving fluid from the port, the second portion 6028 b directingthe fluid substantially toward a central inner diameter of the sealingcuff and thus, toward a staple line of an anastomosis. As will beappreciated by persons skilled in the art, while the sealing cuff isshown with only one port, the cuff can include any number of ports fordelivering sealant to the cuff.

The sealing cuff can have other features that facilitate positioning ofthe sealing cuff around a tubular body organ. As shown in FIG. 203, asealing cuff 6100 can have one or more extension ports 6114, 6116 formedin an outer surface 6112. One or more of the extension ports 6114, 6116can have an inner diameter DP sized and shaped to receive a graspingtool therein. The extension ports can have various features. As shown,the extension port 6114 can have an inner lumen 6118 that determinateson the outer surface 6112 of the sealing cuff 6100 so as to notinterfere with the interior chamber 6106 of the cuff 6100. In anotherembodiment, the inner lumen 6118 of the extension port 6114 can be incommunication with the interior chamber 6106 of the cuff such that fluidcan be delivered into the interior chamber 6106 therethrough, such asthrough a tube (not shown) extending between the inner lumen 6118 and anouter. Any number of the extension ports can have an inner lumenconfigured to deliver fluid to the interior chamber 6106. The innerlumen 6118 can be substantially perpendicular to the outer surface 6112of the sealing cuff 6000 or can be disposed at other angles relative tothe outer surface 6112 of the cuff 6000. For example, as shown in FIG.203, the sealing cuff 6100 can include the first and second extensionports 6114, 6116, the first extension port 6114 being positioned about90 degrees relative to the second extension port 6116. In anotherembodiment (not shown), any number of extension ports can includefeatures for angularly positioning the extension port relative to theouter surface of the cuff, such as a ball and socket joint. Theextension ports can include locking mechanisms configured to lock theport at a desired position. As will be appreciated by a person skilledin the art, the sealing cuff 6100 can include any number of extensionports positioned at any number of locations around the sealing cuffselected so as to not substantially interfere with delivery of the cuff6100 into a patient's body. The inner lumen 6118 can be cylindrical inshape and the inner diameter DP can be in the range of about 19 to 35mm. The second extension port 6116 can include an inner lumen 6120 beingsized and shaped substantially the same as the inner lumen 6118, or theinner lumen 6120 can have a different size and shape. A sealing cuff caninclude features that facilitate a user locating a position of the cuffwhen the cuff is in a patient. For example, the cuff and/or the grasperscan be configured to emit light.

A sealing cuff can include other features that help hold the sealant ina desired position between the tubular body organ and the inner surfaceof the sealing cuff. For example, FIG. 204A illustrates a perspective,partial cross-sectional view of a sealing cuff 6200 having suture 6232woven across an inner surface 6204 of the sealing cuff 6200. The strandof suture 6232 can be provided in a criss-crossed pattern formingintersecting triangles across the inner surface 6204 of the cuff. Inanother embodiment (not shown), the strand of suture 6232 can includemultiple strands of suture that can be woven in various patterns acrossthe inner surface 6204 of the cuff 6200. In general, this suture 6232can be used to hold the sealant away from the inner surface 6204 of thesealing cuff 6200 to prevent sealant from solidifying thereon and cantherefore facilitate removal of the cuff 6200 from a patient's body. Thesuture 6232 can be attached to the sealing cuff 6200 in various ways.For example, a plurality of attachment points 6234 can be formed on aproximal end 6200 p of the cuff 6200 and spaced equally about thecircumference of the proximal end 6200 p of the cuff 6200. As shown inFIG. 204B, a passageway 6236 can be formed around the circumference ofthe proximal end 6200 p of the cuff 6200 and can have an elongate member6238, e.g. a second strand of suture, extending therethrough. Thepassageway 6236 can further include a plurality of radial openingsformed therein, each radial opening 6240 being substantiallyperpendicular to the passageway 6236, as shown in FIG. 204B. Each radialopening 6240 can allow the first strand of suture 6232 to passtherethrough from the inner surface 6204 of the cuff 6200, around thesecond strand of suture 6236, and back through the radial opening 6249toward the inner surface 6204 of the cuff 6200, as shown in FIG. 204B.In use, the second strand of suture 6236 can be cut to release the firststrand of suture 6232 from the inner surface 6204 of the cuff.

A sealing cuff according to any of the exemplary embodiments can beformed from various materials. Preferably, the sealing cuff is formedfrom a substantially rigid material so that it is configured towithstand the forces applied to the cuff sealant is injected through thedelivery tube and into an anastomosis. A sealing cuff can be formed intoa single, unitary structure, such as via injection molding, or intomultiple pieces joined together using any known fixation techniques.

Sealants

A sealant can have various formulations and differing viscosity andcuring behavior. Generally, a sealant can be made from a biocompatibleand bioabsorbable material that can be configured to transition from afirst, liquid state to a second, solidified state via a curing process,such as a polymerization reaction. The first state can be a softenedstate, e.g., a fluid, a gel, a foam, etc. and the second state can be ahardened state, e.g., a solid, a rigid member, etc. When the sealant isin the first, softened state, the sealant can flow through the deliverytube and into the sealing cuff, as described in greater detail below.The sealant can transition from the first, softened state to the second,solidified state after a predetermined amount of time. In certainaspects, the sealant can be formed from biologic material. In someembodiments, the sealant can assist in wound healing by releasingvarious chemical compounds, during and/or after curing of the sealant ina patient's body. By way of non-limiting example, the sealant can beconfigured to release a therapeutic drug, such as fibrin, thrombin, etc.over time to aid the tissue in healing near the location of the sealantin a body. In one embodiment, a fibrin sealant can include two reactivecomponents combined immediately prior to delivery into a patient, suchas Thrombin and a biologically active component (BAC2), Fibrinogen andFactor XIII In certain aspects, the components can be provided in a 5:1volumetric ratio of BAC2 to Thrombin. While the resulting sealant canhave different viscosity and curing behavior depending on itsformulation, this exemplary formulation of sealant can have a viscosityin the range of about 1 cp to 90 cp after the components have been mixedand the polymerization reaction has started, and the sealant can cure toa solidified state in about 3 minutes.

FIG. 205A illustrates a first component 6340 of a sealant 6300positioned in an injection syringe 6342. As shown, the syringe caninclude a plunger 6341 for drawing the component 6340 therein. Thesyringe 6342 can be configured to introduce gas, e.g. air, into thecomponent 6340 through various techniques. For example, an opening 6344can be formed in a needle 6346 of the injection syringe 6342 so that aircan be introduced into the component 6340 as it is drawn into thesyringe 6342. This first component 6340 can be mixed with one or moreadditional components (not shown) immediately prior to or duringinjection into a patient, and these additional components can also havegas introduced therein. The presence of gas in one or more of thecomponents of the sealant 6300 can form air pockets/closed cells 6348 asthe sealant 6300 has solidified into a staple line 6350, as shown inFIG. 205B, resulting in a sealant 6300 that has increased flexibility inits solidified form than if the sealant 6300 lacked these airpockets/closed-cells 6348. This can allow the sealant 6300 to moveradially and longitudinally, in coordination with a movement of atubular body organ, as the organ radially expands, contracts, and/ortwists during normal bodily function. Further, this preparationtechnique can decrease an amount of sealant 6300 that is applied to asealing cuff because the gas can form the closed-cells 6348 in thesealant 6300 that increase the overall volume for a given mass ofsealant 6300. The presence of these closed-cells 6348 can act as avisual indicator to a user regarding the location and/or thickness ofthe sealant 6300.

Expandable Devices

An expandable device can be used in conjunction with a sealing cuff tohold the sealant in a desired position as the sealant cures from theliquid state to the solidified state. In general, the expandable devicesprovided herein can be positioned inside of a tubular body organ in acompressed position and can move to an expanded position in which thedevices expand against an inner surface of the tubular body organ. Thiscan force an outer surface of the tubular organ toward the inner surfaceof sealing cuff and can help hold the sealant in this position toachieve a complete seal around the anastomosis. An expandable device canhave various sizes, shapes, and configurations. In some embodiments, anexpandable device can include first and second expandable members sothat the first expandable member can be positioned on a first side ofanastomosis and the second expandable member can be positioned on secondside of the anastomosis. In certain aspects, the expandable device canbe expanded/inflated by delivering liquid or gas to the expandablemembers. In one embodiment shown in FIG. 206A, an expandable device 6400can include first and second expandable members 6410, 6412, i.e.inflatable balloons, coupled to an elongate member 6416, such as acylindrical rod, via a coupling mechanism 6417. The elongate member 6416can be configured to mate with a distal end 6418 d of a scoping device6418, as shown, to allow a user to visualize the expandable members6410, 6412 when the expandable device 6400 is positioned inside of atubular body organ (not shown). The first and second expandable members6410, 6412 can be fixedly coupled to the elongate member 6416 and spacedapart along an axial length of the elongate member 6416. The first andsecond expandable members 6410, 6412 can be sealed around the elongatemember 6416 using any attachment mechanism known in the art, such as anadhesive. As a result, the elongate member 6416 can extend through acentral longitudinal axis of each of the first and second expandablemembers 6410, 6412 without interfering with the expansion andcompression of the expandable members 6410, 6412. As will be appreciatedby a person skilled in the art, the elongate member 6416 can be madefrom various materials and can be flexible or semi-flexible so as toallow the elongate member to navigate a tortuous tubular body organ.

The device can include various features for delivering fluid, e.g.liquid or gas, to the expandable members. As shown in FIG. 206A, theelongate member 6416 can have proximal and distal terminal ends 6416 p,6416 d, and an inner lumen extending 6420 therethrough from the proximalterminal end 6416 p of the elongate member 6416 and terminating proximalto the distal terminal end 6416 d. The inner lumen 6420 of the elongatemember 6416 can have one or more inflation lumens disposed therein fordelivering fluid, e.g. liquid or gas such as saline, oxygen, carbondioxide, etc., to one or both of the expandable members. For example,the device of FIG. 206A includes first and second inflation lumens 6422,6424. The first inflation lumen 6422 can be configured to deliver fluidtherethrough and into a first exit port (not shown) formed in theelongate member 6416, the first expandable member 6410 being disposedaround the first exit port. Similarly, the second inflation lumen 6424can be configured to deliver fluid therethrough and into a second exitport (not shown) formed in the elongate member 6416, the secondexpandable member 6412 being disposed around the second exit port. Eachof the first and second inflation lumens 6422, 6424 can be coupled tofirst and second fluid sources (not shown) that can allow for selectiveinflation of the expandable members 6410, 6412, e.g. simultaneousinflation of the first and second expandable members 6410, 6412 orsequential inflation of the expandable members 6410, 6412 in any order.As will be appreciated by a person skilled in the art, the expandabledevice can have any number of inflation lumens, such as one inflationlumen in fluid communication with first and second expandable members.The expandable devices can include other features for facilitatingmoving the expandable members from a compressed position to an expandedposition by inflating and deflating the expandable members. For example,the expandable members can include one or more valves (not shown)positioned in any of their respective inflation lumens. In certainaspects, the valves can be configured to close when the expandablemember achieves a certain inflation volume to prevent liquid or gas fromflowing out of the expandable members. After a procedure is performed,the valves can be opened to allow the expandable members to deflate tothe compressed position to facilitate removal of the device from thepatient's body.

The expandable members can have various sizes and shapes in the expandedand compressed positions. When the expandable members of FIG. 206A arein an expanded position, the expandable members 6410, 6412 can besubstantially disc-shaped. The expandable members can have any size andshape configured to expand a tubular body organ, such as spherical,tubular, etc. In general, each of the expandable members can have amaximum diameter in the expanded position that is greater than an innerdiameter of the tubular body organ in its resting state, such as in therange of about 110 to 115% greater than the inner diameter of thetubular body organ. As explained in further detail below, this canfacilitate positioning of the sealant between an outer surface of thetubular body organ and an inner surface of the sealing cuff. Theexpandable members can be formed from various materials that can beinflated, such as rubber, silicone, PET, and Teflon.

FIG. 206B illustrates another embodiment of an expandable device havinga first expandable member 6410′, e.g. a first inflatable balloon,fixedly coupled to a flexible tether 6416′. A second expandable member6412′, e.g. a second inflatable balloon, can be positioned over aproximal terminal end 6416 p′ of a tether 6416′ and can slide along anaxial length of the tether 6416′ in a compressed position so as to allowa user to selectively position the second expandable member 6412′relative to the first expandable member 6410′. The second expandablemember 6412′ can include an inflation lumen 6422′ that can be integrallyformed thereon or the inflation lumen 6422′ can consist of a tuberemovably attachable to the second expandable member 6412′. As in theprevious embodiment, an inflation source (not shown) can be coupled tothe inflation lumen 6422′. The proximal terminal end 6416 p′ of thetether 6416′ can also be coupled to an inflation source (not shown)while a distal terminal end 6416 d′ of the tether 6416′ can be insertedinto the tubular body organ with the first expandable member 6410′fixedly coupled thereto. In certain aspects, the distal terminal end6416 d′ of the tether 6416′ can be attached to an anvil of a circularstapler to allow the expandable device 6400′ to be positioned inside ofthe tubular body organ as the anastomosis is being formed, as will bedescribed in greater detail below. The tether 6416′ can have anti-tanglefeatures, such as being biased to a coiled position, and can be formedfrom a flexible material configured to navigate a tortuous tubular bodyorgan. The tether 6416′ can include a location device (not shown) suchas a magnet, disposed thereon and positioned proximal to the secondexpandable member 6412′, the location device allowing a surgeon todetermine a location of the tether 6416′ relative to an anastomosis.

An expandable device can vary in any number of ways and can include asingle expandable member rather than a plurality of expandable members,as shown in FIGS. 206C and 206D. In the illustrated embodiments,expandable devices 6500, 6500′ can perform many of the functions of theprevious expandable devices 6400, 6400′ using different features. Forexample, expandable members 6510, 6510′ are a single balloon fixedlycoupled to an elongate member, such as the scope 6418 at proximalfixation points 6526 p, 6526 p′ and distal fixation points 6528 p, 6528p′. Each expandable member 6510, 6510′ includes a single inflation lumen6522, 6522′ that can extend along an outer surface 6418, 6418′ of thescope 6418. Alternatively, the expandable member can have an inflationlumen extending through the scope 6418 rather than along an outersurface of the elongate member. The expandable members 6510, 6510′ canbe shaped in various ways. For example, FIG. 206C illustrates theexpandable member 6510 having proximal and distal expandable portions6510 p, 6510 d that form a substantially dumbbell-shape when theexpandable member 6510 is in the expanded position and having anonexpandable central portion 6510 c. FIG. 206D illustrates anexpandable member 6510′ having a substantially cylindrical shape when itis in the expanded position. As in the previous embodiments, a maximumdiameter of each of the expandable members 6510, 6510′ can be selectedso that the maximum diameter is greater than an inner diameter of thetubular body organ in its resting state, that is, before the expandablemembers 6510, 6510′ are positioned therein in the expanded position. Inanother embodiment shown in FIG. 207, the expandable device 6600 caninclude the first and second expandable members 6410, 6412, and caninclude first and second inflation lumens 6622, 6624 terminating indistal ends 6622 d, 6624 d delivered to direct fluid to the firstexpandable member 6410 and the second expandable member 6412,respectively. The expandable device 660 can further include a thirdinflation lumen 6626 having a distal end 6626 d configured to deliverliquid or gas to a central portion of the device, i.e. to the space inbetween the first and second expandable members 6410, 6412. As will bedescribed in greater detail below, this lumen 6626 can deliver liquid orgas to the inner wall of the anastomosis to allow a user to test leakagetherefrom.

As will be appreciated by persons skilled in the art, various inflationfluids (liquid and/or gas) can be delivered to the expandable member(s),such as air, carbon dioxide, saline, water. Additionally, the inflationfluid can be colored, such as by adding methylene blue to the inflationfluid prior to injection, and can be any biocompatible contrast materialknown in the art to facilitate visualization of the surgical procedure.

In other embodiments, the expandable devices can be configured to moveto an expanded position without the use of liquid and inflation lumens.For example, FIGS. 208A-208C, illustrate various embodiments of stentsin their expanded positions. In general, the stents can be configured tomove between a compressed position and an expanded position, but cangenerally be biased to the expanded position. To facilitate delivery ofthe stent into a tubular body organ, the expandable stents can bepositioned within an elongate sheath (not shown) that holds the stent inthe compressed condition and can be removed once the stent is in adesired position relative to an anastomosis. As in the previous devices,the expandable stents can have various sizes, shapes, and configurationsin the expanded position. For example, a stent 6700 of FIG. 208A hasfirst and second expandable members 6710, 6712, each having afrustoconical shaped terminal portion 6732, 6734 and a centralcylindrical portion 6736, 6738 configured to contact an inner wall of atubular body organ adjacent to the anastomosis when the stent 6700 is inthe expanded position. The stent 6700 can be coupled to an elongatemember 6716 or rod having an actuator 6740 extending through theelongate member 6716. The actuator 6740 can be configured to be pulledproximally relative to the elongate member 6716 to deploy the expandablemembers 6710, 6712 to the expanded position of FIG. 208A. A stent 6700′of FIG. 208B can include first and second expandable portions 6710′,6712′ being substantially funnel shaped and having a smaller diameter ata central portion 6736′ thereof than at terminal ends 6732′, 6734′, theterminal ends 6732′, 6734′ being configured to contact an inner wall ofthe tubular body organ at a distance from the anastomosis. Theexpandable portions 6710′, 6712′ can be coupled to a flexible body, suchas a tether 6716 that can have one or more location features (not shown)disposed thereon. A stent 6700″ of FIG. 208C can include elongatebundles of wire 6742 extending along a longitudinal axis of the bodyorgan and coupled to an elongate member 6716″, the bundles of wire 6742defining a first expandable portion 6710 and second expandable portion6712. The proximal and distal ends 6′742 p, 6742 d of the loops can beconfigured to expand against an inner wall of the tubular body organwhile central portions of the loops have a same diameter in the expandedand compressed positions, i.e. have a smaller diameter than the tubularbody organ at the anastomosis. As will be appreciated by persons skilledin the art, the expandable stents can be formed from various materials,such as Nitinol, metal wire, plastics, etc. While the expandable stentsshown in FIGS. 208A-208C all include central portions having a maximumdiameter less than a diameter of the organ at the anastomosis, thestents can include expandable central portions. The stents can vary inany number of ways and can have any combination of features, such asbeing coupled to a scope rather than an elongate member.

An expandable device can include features that facilitate a userlocating a position of the device when it is positioned in a patient.For example, the expandable device can be configured to emit light, suchas by being formed from a material that can emit light.

Delivery of Cuff to an Organ

A surgical procedure can be performed on a patient and can includeremoving a section of a tubular body organ that has an obstruction ortumor therein. This procedure can include, by way of non-limitingexample, a lower anterior resection (LAR) of a rectum. Similarly,although the procedure is illustrated with respect to a tubular bodyorgan, i.e. a rectum, another tubular anatomical structure, can besimilarly treated such as entero-entero anastomosis of an intestine,uretero-uretero anastomosis of a kidney duct, esophagogastricanastomosis in the thorax or neck, aorto-iliac anastomosis, etc. Afterthe section of the tubular body organ is removed, the procedure caninclude reattaching two sections of the tubular, e.g. performing alumen-to-lumen anastomosis, such as using a circular surgical stapler.As will be appreciated by persons skilled in the art, the procedure canbe an open surgical procedure, but is preferably a minimally invasive,laparoscopic and endoscopic surgical procedure in which multipleincisions are formed in a patient, the stomach cavity is insufflatedwith gas, and one or more trocars extend into the incisions and define aworking channel for instruments to be inserted therethrough. A scope canbe inserted through one of the incisions to allow a surgeon to visualizethe surgical site. Alternatively or additionally, a scope can beinserted through a patient's body, i.e. through an anus to facilitatevisualization of the surgical site. As described in greater detailbelow, various devices can be delivered endoscopically to the surgicalsite, including the expandable devices and the circular surgicalstapler.

FIGS. 209A-209E illustrate an exemplary embodiment of a surgicalprocedure for stapling and sealing a tubular body organ using thesealing cuff Although the procedure is illustrated with respect to thesealing cuff 6000 of FIGS. 202A-202C and the surgical stapler 200 ofFIG. 207, the sealing cuff 6000 can include any combination of featuresdescribed herein. Although the procedure is illustrated with respect tostapling, a tubular body organ can be sealed as discussed herein inconjunction with a type of fastener other than staples, e.g., clips,sutures, etc. While the surgical procedure is shown without anexpandable device positioned inside of the tubular body organ, any ofthe devices herein can be used to expand the organ and force the outersurface of the organ toward the inner surface of the cuff to hold thesealant therebetween.

FIG. 209A illustrates first and second sections 6800 a, 6800 b of atubular body organ 6800 after a portion of the organ 6800 has beenremoved and prior to the first and second sections 6800 a, 6800 b beingjoined in an anastomosis. The first section 6800 a of the tubular bodyorgan 6800 includes the cartridge assembly (not shown) of the surgicalstapler 200 positioned therein and having a first shaft portion 262 aextending therefrom. As shown in FIG. 209B, the cartridge assembly canbe held within the first section 6800 a of the organ 6800 a via one ormore strands of suture 6802 a. The second section 6800 b of the tubularbody organ 6800 includes the anvil (not shown) of the surgical stapler200 positioned therein and having the second shaft portion 262 bextending therefrom. The anvil can also be held within the secondsection 6800 b of the organ via one or more strands of suture 6802 b.Prior to joining the two sections 6800 a, 6800 b, the sealing cuff 6000can be introduced onto the tubular body organ 6800 by sliding the cuff6000 over the second shaft portion 262 b and the second section 6800 bof the tubular body organ.

With the sealing cuff 6000 positioned on the second section 6800 b ofthe tubular body organ 6800, the sealing cuff 6000 can optionally beheld in position by inserting a first grasper tool 6818 directly througha first incision in a patient (without a trocar) or through a trocar6804 and into a first extension port 6114 formed on the sealing cuff6000, as shown in FIG. 209B. Optionally, a second grasper tool (notshown) can be inserted directly through a second incision in a patient(without a trocar) through a second trocar (not shown) and into thesecond extension port 6116. The grasper tools can be manipulated to movethe sealing cuff 6000 axially along the tubular body organ 6800 and/orcan rotate the sealing cuff 6000 relative to the organ 6800. In certainaspects, when the extension ports include a joint that allows angle(s)of the extension ports to be adjusted relative to an outer surface ofthe cuff, the grasper tools can be used to change an angle of one ormore of the ports relative to the outer surface of the cuff, and each ofthe ports can be locked in an angulated position when a desired angle isachieved. With the sealing cuff 6000 positioned away from terminal ends6806 a, 6806 b of the first and second sections 6800 a, 6800 b of thetubular organ 6800, the anvil 254 and the cartridge assembly 252 can bejoined together, capturing tissue therebetween to begin forming ananastomosis. As shown in FIG. 209C, the first and second sections 6800a, 6800 b of the tubular organ 6800 can be moved toward one another andthe first and section portions 262 a, 262 b of the shaft 262 can then becoupled together to prepare the surgical stapler 200 to form ananastomosis. As shown, the anvil 254 and the cartridge assembly 252 ofthe stapler 200 can then be separated at a distance. The actuator (notshown) on the stapler 200 can be manipulated by a user, and this canretract the anvil 254 toward the cartridge assembly 252 until the anvil254 and cartridge assembly 252 capture a portion of the tubular bodyorgan 6800 therebetween, as shown in FIG. 209D. With the anvil 254 andcartridge assembly 252 positioned adjacent to one another, the device200 can fire staples from the cartridge assembly 252 in a circularpattern around a circumference of the tubular body organ 6800, formingan anastomosis 6808. After the anastomosis 6808 is formed, the surgicalstapler 200 can be removed from the patient, such as by retracting thestapler 200 proximally and out of the rectum of the patient.

The sealing cuff 6000 can be positioned over the anastomosis 6808 invarious ways and can be moved toward the anastomosis 6808, such as bysliding the cuff 6000 relative thereto, as shown in FIG. 209E. Theinterior chamber 6006 of the sealing cuff 6000 can be positioned overthe anastomosis 6808 so that the sealing cuff 6000 can direct thesealant 6300 toward the anastomosis 6808. For example, the sealing cuff6000 can be substantially centered over the anastomosis 6808, that is,the second portion 6028 b of the passageway 6028 can be aligned with acentral longitudinal axis LA of the anastomosis 6808 to facilitatedelivery of the sealant 6300 thereto. If the sealing cuff is configuredto emit light, as previously mentioned, a user can visually monitor aposition of the cuff based in part on a location of the emitted light.As shown in FIG. 209F, with the sealing cuff 6000 in the desiredposition, the sealant 6300 can be introduced into the delivery tube 6026when the sealant 6300 is in a liquid state and can pass through the port6024 and into the interior chamber 6306 of the cuff 6000. The sealant6300 can seep into the staple line of the anastomosis 6808 and cansolidify therein so as to prevent leaks. As will be appreciated bypersons skilled in the art, a sufficient volume of the sealant 6300 canbe delivered into the interior chamber 6306 so that the sealant 6300 ispositioned 360 degrees around the anastomosis 6808. The protrusions 6008formed on the inner surface 6004 of the sealing cuff 6000 can helpdistribute the sealant 6300 evenly across the anastomosis 6808 and canensure that gravity does not pull the sealant 6300 toward a portion ofthe sealing cuff 6000 closest to the ground. The sealing cuff 6000 canremain positioned around the anastomosis 6808 until the sealant 6300transitions from the liquid state to the solidified state for apredetermined amount of time, at least as long as the curing time of thesealant 6300. In certain aspects, the sealing cuff 6000 can be rotatedaround the body lumen as the sealant 6300 is curing from the liquid tothe solidified state to facilitate uniform coverage of the sealant 6300around the anastomosis. After the sealant 6300 has cured and is in itssolidified state, one or more grasping tools (not shown) can contact andgrasp the sealing cuff 6000 at various locations, such as along the tabs61012 a, 6012 b, 6014 a, 6014 b or in the extension ports 6114, 6116.The grasping tools can be used to pull apart the sealing cuff 6000 andremove the breakaway sections so that the first reinforcement rib 6012is detached from the second reinforcement rib 6014, the sealing cuff6000 having a C-shaped profile, as in FIG. 209G. If the cuff includessuture woven on an inner surface thereof, as in the cuff 6200 previouslydescribed, the second strand of suture 6236 can be cut to release thefirst strand of suture 6232 from the inner surface 6204 of the cuff6000, thereby releasing the solidified sealant 6300 from the cuff 6000.The sealing cuff 6000 can be removed from the tubular body organ 6800and withdrawn from the patient's body, leaving a substantiallyring-shaped structure of solidified sealant 6300 b around theanastomosis 6808. The sealant 6300 b can be absorbed into the body aftera predetermined amount of time, such as after two weeks. Preferably,this time is selected so that the tubular body organ 6800 issubstantially healed at the anastomosis 6808.

Delivery of Expandable Devices to an Organ

While the surgical procedure of FIGS. 209A-209G includes formation ofthe anastomosis and positioning of the sealing cuff around ananastomosis, the expandable devices disclosed herein can be used inconjunction with the sealing cuff to hold the sealant between the outersurface of the organ and the inner surface of the cuff. An expandabledevice can be delivered to the anastomosis in various ways, such as viathe circular surgical stapler or a scope. For example, as shown in FIG.210A, the anvil 254 of a surgical stapler 200 can be used to facilitatepositioning of the expandable members 6410, 6412 inside of the tubularbody organ 6800 prior to an anastomosis being formed. A tether 6416′ andtwo expandable members 6410, 6412 can be coupled to a distal terminalend 254 d of the anvil 254, as shown in FIG. 210B. The tether 6416′ canbe in a coiled position to prevent the tether 6416′ from tangling aroundstructures in the tubular body organ 6800. The tether 6416′ canoptionally include a location device 6430, such as a magnet, configuredto allow a surgeon to visually monitor a position of the tether 6416′relative to the anastomosis. After the surgical stapler 200 fires thestaples and forms the anastomosis 6808, the proximal end 6416 p′ of thetether 6416′ can be detached from the anvil 254 and pulled proximallythrough the tubular body organ 6800 until the proximal end 6416 p′ ispositioned outside of a patient's body. Alternatively, as shown in FIG.210C, the tether 6416′ and the expandable members 6410, 6412 can becoupled to the distal terminal end 6418 d of the scoping device 6417 viathe elongate member 6416 or rod. The scope 6418, elongate member 6416,and the expandable members 6410, 6412 can be inserted trans-anallythrough the tubular body 6800 and after a user confirms a positioning ofthe expandable members 6410, 6412 near the anastomosis 6800, the tether6416′ can be detached from the scoping device 6418. Any of theexpandable devices/expandable members can be configured to emit light,and a user can include locate a position of the expandabledevice/expandable members relative to the anastomosis based in part on alocation of the emitted light. The tether 6416′ can be pulled proximallyuntil the proximal end 6416 p′ of the tether 6416′ is positioned outsideof a patient's body. In both of these embodiments, a surgeon canposition the first expandable member 6410 on a first side of theanastomosis 6808, i.e. distal to the anastomosis 6808, while the surgeoncan position a second expandable member 6412 on a second side of theanastomosis 6808, i.e. proximal to the anastomosis 6808. With theexpandable members 6410, 6412 so positioned, the proximal end 6416 p′ ofthe tether 6416′ can be coupled to one or more inflation sources (notshown) and can deliver gas or liquid to the expandable members 6410,6412. For example, a first inflation source (not shown) can be fluidlycoupled to a first inflation lumen 6422 and can inflate the firstexpandable member 6410 to the expanded position, as shown in FIG. 210D.After the first expandable member 6410 is in the expanded position, asecond inflation source (not shown) can be coupled to a second inflationlumen 6424 to inflate the second expandable member 6412 to the expandedposition, as shown in FIG. 210E. The order of the steps can vary in anynumber of ways, for example, the first expandable member 6410 can beinflated at the same time as the second expandable member 6412 isinflated or the expandable members 6410, 6412 can be inflatedsequentially, and this can be repeated any number of times until adesired amount of force is exerted on the tubular body organ 6800. Inanother embodiment shown in FIGS. 211A-211B, a scope such as asigmoidoscope can be inserted trans-anally into the tubular body organand can have the single expandable member 6500 positioned thereon. Whenthe scope is inserted in the anus, as shown in FIG. 211A, the expandablemember 6500 can be in the compressed position. More specifically, asurgeon can insert the expandable member 6500 into the anus of a patientso that the first coupling member 6526 d is positioned on a first sideof the anastomosis 6808, i.e. distal to the anastomosis 6808, and sothat the second coupling member 6526 p is positioned on a second side ofthe anastomosis 6808, i.e. proximal to the anastomosis 6808. The centralportion 6510 c of the expandable member 6500 can be axially aligned witha central portion of the sealing cuff 6000, as shown in FIG. 211B.Further, the sealing cuff 6000 can be substantially centered over theanastomosis 6808, that is, the second portion of the passageway of thecuff 6000 can be aligned with a central longitudinal axis LA of theanastomosis 6808 to facilitate delivery of the sealant 6300 to theinterior chamber 6006 of the cuff 6000 and to the anastomosis 6808. Asurgeon can confirm a positioning of these devices using visualizationtechniques known in the art. The central portion 6510 c of theexpandable member 6500 can be positioned adjacent to the anastomosis6800. As in the other devices, the expandable member 6500 and sealingcuff 6000 can be positioned so that the cuff 6000 is substantiallycentered over the anastomosis 6808. As shown in FIG. 211C, as gas orfluid is delivered to the expandable member 6500 through the inflationlumen 6522, the first and second expandable portions 6510 p, 6510 dexert a force against an inner surface of the tubular body organ 6800and increase an outer diameter of the tubular body organ 6800. Thisforces the outer surface of the tubular body organ 6800 toward the innersurface 6004 of the sealing cuff 6000. As will be appreciated by aperson skilled in the art, the fluid can be delivered to the expandablemember 6500 until a desired volume or pressure is achieved. After thesealant has substantially cured to its solidified state, the expandablemember 6500 can be moved to the compressed position by releasing thefluid therefrom, and then retracted proximally and removed from thepatient's body.

Any of the expandable devices disclosed herein can be positionedproximate to the anastomosis and can move from a compressed position toan expanded position to increase an outer diameter of portions of thetubular body organ adjacent to or surrounding the anastomosis. Thisincludes the expandable devices and the expandable stents previouslydescribed. For another example, the expandable device 6400′ of FIG. 206Bcan be used to increase an outer diameter of the tubular body organ 6800adjacent to or surrounding the anastomosis 6808. In this embodiment, asurgeon can selectively position the second expandable member 6412′relative to the first expandable member 6410′. More specifically, asurgeon can position the first expandable member 6410′ on the firstside, i.e. distal to the anastomosis 6808 and the location of theexpandable member 6410′ can be monitored using the scope 6418, as shownin FIG. 212A. Alternatively or additionally, a surgeon can monitor thelocation of the expandable member 6410′ using known imaging techniquesto identify the location device 6430, e.g. magnet, coupled to theproximal end 6416 p′ of the tether 6416′ and to the distal end 6416 d ofthe elongate member 6416. A surgeon can detach the tether 6416′ from theelongate member 6416 using various techniques, such as by inserting agrasper tool (not shown) into the tubular body organ 6808 and severingthe tether 6416′, and the scope 6418 can be retracted proximally untilit is positioned outside of the patient, as in FIG. 212B. An inflationsource (not shown) can be coupled to the proximal end 6416 p′ of thetether 6416′ and can deliver liquid or gas to expand the expandablemember 6410′. As shown in FIG. 212C, the scope 6418 can be inserted intothe tubular body organ 6800 and can monitor a degree of inflation andpositioning of the first expandable member 6410′ relative to theanastomosis 6808. The second expandable member 6412′, e.g. a secondinflatable balloon, can be positioned over the proximal terminal end6416 p′ of the tether 6416′ when the proximal terminal end 6416 p′ ispositioned outside of the patient's body, and the second expandablemember 6412′ can slide along an axial length of the tether 6416′ in acompressed position. In this way, a user can selectively position thesecond expandable member 6412′ relative to the first expandable member6410′ and relative to the anastomosis 6800, and the user can monitorthis positioning using the scope 6418. After the second expandablemember 6412′ is in a desired position, the proximal terminal end 6416 p′of the tether 6416′ can be coupled to an inflation source (not shown)and can be activated to expand the second expandable member 6412′, asshown in FIGS. 212D and 212E. The scope 6418 can be retracted proximallyand removed from the patient's body. As a procedure is performed on thetubular body organ 6800, such as delivering sealant 6300 into thesealing cuff 6000 positioned around the anastomosis 6808, a volume ofthe expandable members 6010′, 6012′ can be adjusted as desired to ensurethat the outer surface of the tubular body organ 6800 and the sealingcuff 6000 hold the sealant 6300 during the curing process. After thesealant 6300 has substantially cured to its solidified state, the firstand second expandable members 6010′, 6012′ can be deflated to thecompressed position and then retracted proximally and removed from thepatient's body.

Methods for Testing a Seal of an Organ

Methods for testing a seal of an anastomosis can improve a surgicaloutcome by providing feedback to a surgeon as to the effectiveness of aseal along an anastomosis. More specifically, this can allow a surgeonto intervene and correct any leaks prior to completing the procedure. Aleak test can be performed before a sealant is applied to an anastomosisand if liquid or gas fails to leak out of the staple line of theanastomosis, a surgeon may determine that it is not necessary to apply areinforcing sealant to the anastomosis. As another example, the leaktest can be performed after the sealant is applied to allow a surgeon toconfirm that the sealant has penetrated the staple line and cured to itssolidified state. While any of the expandable members provided hereincan be modified to include an additional lumen for delivering liquid orgas to the portion of the tubular body organ adjacent to theanastomosis, specific reference is made to the expandable device of FIG.207 for performing a leak test. After fluid has been delivered to thedevice so that the expandable members 6410, 6412 are in their expandedposition, as shown in FIG. 213, fluid or gas can be delivered to thethird inflation lumen 6626. This fluid can be trapped between first andsecond expandable members 6410, 6412, thereby exerting pressure on theanastomosis 6808. With the expandable members 6410, 6412 so positioned,leaks are more likely to occur at the staple line due to stretching ofthe tissue. As the surgeon continues to deliver the liquid or gas tothis portion of the anastomosis 6808 until a desired volume and pressureis achieved in the expandable members 6410, 6412, any leaks can beobserved using known imaging techniques. For example, a surgeon canconfirm the presence of leaks by visually identifying gas bubbles orliquid moving out of the tubular body organ 6800 through the stapleline. As previously mentioned, the use of dyes or contrast material canassist a surgeon with visually identify these leaks. The method canfurther include delivering therapeutic agents through the tubular bodyorgan 6800 and into the anastomosis 6808 using the inflation lumen 6626.Such therapeutic agents can include, by way of non-limiting example,additional sealant material, adhesives, coagulants, promoters ofhealing, oncologic medicines, and colonic stents. The method can beperformed in other ways. For example, a fourth lumen (not shown) canalso be provided in the expandable device 6600 and a surgeon can usethis fourth lumen to drain gas or liquid from the space between theexpandable members 6410, 6412, such as to allow the leak test to beperformed multiple times and/or to deliver various therapeutic agents,gas, liquid, etc. to the anastomosis 6808.

Other methods for performing a leak test are also shown in FIGS. 214Aand 214B, which illustrate pressure being applied to the anastomosis6808 at various locations. For example, FIG. 214A illustrates anexpandable device 6900 having first and second mandrels 6910, 6912having a thickness that increases from a central portion of the mandrels6910, 6912 to an outer circumference thereof for facilitating a sealbetween the expandable device 6900 and the tubular body organ 6800. Asshown, a side portion 6910 s, 6912 s of the mandrels 6910, 6912 can havean increased thickness near the inner wall of the tubular body organ6800 so that a greater surface area of the expandable member 6910, 6912contacts the inner surface of the organ 6800. In this way, theexpandable device 6900 can withstand increased pressures and maintain ina substantially fixed position relative to the anastomosis 6808 as thefluid is delivered into a sealed space 6914 in between the first andsecond expandable mandrels 6910, 6912. As in the previous embodiment,the first expandable member 6910 can be inflated by delivering fluidthereto via a first inflation lumen 6922 and the second expandablemember can be inflated by delivering fluid thereto via a secondinflation lumen 6924 simultaneously or successively in any order. Asshown in FIG. 214A, once the expandable mandrels 6910, 6912 are in theexpanded positions, fluid such as gas can be delivered into the space6914 between the mandrels 6910, 6912 via a third inflation lumen 6926.This can ensure that fluid does not leak out proximal or distal to theanastomosis 6808, as such leaking could decrease a pressure beingapplied to the anastomosis 6808 and thus, decrease an effectiveness ofthe leak test.

FIG. 214B illustrates a method for performing a leak test that includesa single expandable mandrel 6900′ having proximal and distal portions6912′, 6910′, sized and shaped similar to the expandable mandrels 6910,6912 of FIG. 214A. Fluid can be delivered to the expandable mandrel6900′ via the first inflation lumen 6922′ to expand the mandrel 6900′.In the expanded position, the expandable mandrel 6900′ has an enlargedcentral portion 6900 c′ positioned adjacent to and in direct contactwith the anastomosis 6800. The central portion 6900 c′ of the expandablemandrel 6900′ can exert a force perpendicular to the anastomosis 6808and forming a staple line support zone, as shown. In this way, theexpandable mandrel 6900′ can prevent the anastomosis 6808 fromcompressing radially inward as the sealant 6300 is curing therearoundand held in position in the cuff 600. Radial compression of the stapleline is undesirable because it could decrease a diameter of the tubularbody organ 6800 and prevent liquids and solids from passingtherethrough. When the expandable mandrel 6900′ is so positioned, fluidcan be delivered to a first chamber 6902′ positioned distal to theanastomosis 6808 via a second inflation lumen 6924′, the first chamber6902′ being positioned between the distal portion 6910′ and theanastomosis 6808. Simultaneously or sequentially, fluid can be deliveredto a second chamber 6904′ positioned proximal to the anastomosis 6808via a third inflation lumen 6926′, the second chamber 6904′ beingpositioned between the proximal portion 6912′ and the anastomosis 6808.As in the previous embodiments, a surgeon can visually identify anyleaks from the anastomosis 6808. If leaks are observed, a surgeon canapply sealant 6300 to the anastomosis using a sealing cuff 6000, etc.and perform the leak test any number of times until the surgeondetermines that the leaks are repaired.

After the leak test is performed and/or where a sealant has been curedto reinforce the anastomosis, the liquid or gas can be removed from theexpandable member so that the expandable member is in the compressedposition and the expandable device can be retracted proximally and outof the patient's body.

Reprocessing

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

In some embodiments, devices described herein can be processed beforesurgery. First, a new or used instrument, which can include an adjunctmaterial, is obtained and if necessary cleaned. The instrument can thenbe sterilized. In some embodiments, the instrument can be dried, e.g.,in an oven, together with a desiccant item, which can have a greateraffinity for moisture than the adjunct material. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag or a foil bag. The container andinstrument are then placed in a field of radiation that can penetratethe container, such as gamma radiation, x-rays, or high-energyelectrons. The radiation kills bacteria on the instrument and in thecontainer. In another sterilization technique, the instrument is placedin a first container, such as a plastic or TYVEK bag, having a vaporpermeable backing. The first container can then be packaged in a secondcontainer, e.g., a foil bag, which can be left open. The first andsecond containers, together with the instrument, can undergo ethyleneoxide sterilization. The second container can then be sealed to preventmoisture exposure. Prior to sealing, a desiccant item may be included inat least one of the first and second containers to further preventchanges to one or more device components. In both techniques, thesterilized materials can then be stored in the sterile container(s) tokeep the materials sterile until the container(s) is/are opened in themedical facility.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

1.-19. (canceled)
 20. An adjunct for use with a surgical stapler,comprising: a main body having a core layer formed of first fibers and asupport layer formed of second fibers, wherein the core layer has aweave density that is less than a weave density of the support layer;and a flexible, non-woven layer attached to an outward facing surface ofthe main body, wherein the flexible, non-woven layer is configured toreleasably retain the adjunct on a cartridge or anvil of a surgicalstapler.
 21. The adjunct of claim 20, wherein the flexible, non-wovenlayer comprises polydioxanone.
 22. The adjunct of claim 20, wherein thefirst fibers are made of a first bioabsorbable polymer and the secondfibers are made of a second bioabsorbable polymer that is different thanthe first bioabsorbable polymer.
 23. The adjunct of claim 20, whereinthe first fibers and the second fibers are made of the samebioabsorbable polymer.
 24. The adjunct of claim 20, wherein at least oneof the first fibers and the second fibers are monofilament fibers. 25.The adjunct of claim 20, wherein at least one of the first fibers andthe second fibers are multi filament fibers.
 26. The adjunct of claim20, wherein the adjunct is configured to apply a pressure of at least 3gf/mm² to the captured tissue for at least 3 days when the adjunct isstapled thereto.
 27. A staple cartridge for use with a surgical stapler,comprising: a cartridge body having a plurality of staples partiallydisposed therein, the plurality of staples being configured to bedeployed into tissue; and an adjunct configured to be releasablyretained on the cartridge body, wherein the adjunct comprises, a mainbody having a core layer formed of first fibers and a support layerformed of second fibers, wherein the core layer has a weave density thatis less than a weave density of the support layer; and a flexible,non-woven layer attached to an outward facing surface of the main body,wherein the flexible, non-woven layer is configured to releasably retainthe adjunct on a cartridge or anvil of a surgical stapler.
 28. Thestaple cartridge of claim 27, wherein the flexible, non-woven layercomprises polydioxanone.
 29. The staple cartridge of claim 27, whereinthe first fibers are made of a first bioabsorbable polymer and thesecond fibers are made of a second bioabsorbable polymer that isdifferent than the first bioabsorbable polymer.
 30. The staple cartridgeof claim 27, wherein the first fibers and the second fibers are made ofthe same bioabsorbable polymer.
 31. The staple cartridge of claim 27,wherein at least one of the first fibers and the second fibers aremonofilament fibers.
 32. The staple cartridge of claim 27, wherein atleast one of the first fibers and the second fibers are multi filamentfibers.
 33. The staple cartridge of claim 27, wherein the adjunct isconfigured to apply a pressure of at least 3 gf/mm² to the capturedtissue for at least 3 days when the adjunct is stapled thereto.